Pure Global
Home/Indonesia Database/Authorized Representative
๐Ÿ‡ฎ๐Ÿ‡ฉ

PT. MINDRAY MEDICAL INDONESIA

Authorized Representative in Indonesia

Menara DEA II Lt.17, Jl. Mega Kuningan Barat Kav.E4.3 No.1-2, Kel. Kuningan Timur, Kec.Setiabudi Kawasan Mega Kuningan, Jakarta Selatan
643 Products Represented
43 Manufacturers
Total Products
643
Manufacturers
43
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
99 products
15.4%
Kelas Resiko : B
445 products
69.2%
Kelas Resiko : C
90 products
14.0%
Kelas Resiko : D
9 products
1.4%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (643)
Complete portfolio registered with BPOM

MINDRAY ME7 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

MINDRAY ASO/CRP/RF Triple Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

MINDRAY Hypertension Multi Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

MINDRAY ALD Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2025

MINDRAY M-5LEO (II) LYSE

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

MINDRAY LC LYSE

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

MINDRAY M-5LEO (I) Bright

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

MINDRAY Urine Sediment Control Level III

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

MINDRAY BS-230 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2025

MINDRAY Hypertension Multi Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2025

MINDRAY ALD II Aldosterone (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

MINDRAY Urine Sediment Control Level I

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

MINDRAY ACTH Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

MINDRAY Urine Sediment Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

MINDRAY ACTH Adrenocorticotropic hormone (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

MINDRAY ACTH Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

MINDRAY DHEA-S Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

MINDRAY Urine Sediment Control Level II

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

MINDRAY ACTH Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

MINDRAY AP-100 Automated Dosing System and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

MINDRAY VB12 CAL Vitamin B12 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2024

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 16, 2024

MINDRAY Totalฮฒ Human Chorionic Gonadotropin (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

MINDRAY BS-600M Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 10, 2024

MINDRAY Reagent Strips for Urinalysis (URS-11MRQ)

Manufacturer:

JILIN LEADING BIO-ENGINEERING CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2024

MINDRAY MYO Myoglobin (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2024

MINDRAY AF-300 Automated ID/AST Identification and Susceptibility Testing System and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 4, 2024

MINDRAY Diagnostic Ultrasound System Nuewa I9 Exp with Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 20, 2024

MINDRAY sCD14-ST Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2024

MINDRAY Digital Radiography System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 12, 2024

MINDRAY Large Fragment Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 9, 2024

MINDRAY C-Reactive Protein (CRP) Kit (Latex Particle-Enhanced Immunonephelometry Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2024

MINDRAY LDL-Cholesterol Kit (Direct Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2024

MINDRAY HBsAg Hepatitis B Surface Antigen (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 30, 2024

MINDRAY Anti-TP Antibody to Treponema pallidum (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2024

MINDRAY M-53LH Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

MINDRAY TG Triglycerides Kit (GPO-POD Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2024

MINDRAY Anti-HCV Antibody to Hepatitis C Virus (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Oct 23, 2024

MINDRAY Cytomegalovirus IgM (CLIA) Calibrators included

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 1, 2024

MINDRAY Reagent Strips for Urinalysis (URS-14MRQ)

Manufacturer:

JILIN LEADING BIO-ENGINEERING CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 27, 2024

MINDRAY HbA1c Control P

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

MINDRAY BS-2800M Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2024

MINDRAY HbA1C Control N

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

MINDRAY HbA1c Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

MINDRAY Lipids Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

MINDRAY ClinChem Multi Control (level 1)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2024

MINDRAY ClinChem Multi Control (level 2)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 19, 2024

MINDRAY Vital Signs Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2024

MINDRAY Vital Signs Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2024

MINDRAY Syringe Pump

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2024

MINDRAY Multi Sera Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2024

MINDRAY Infusion Pump

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2024

MINDRAY Syringe Pump

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2024

MINDRAY EU-50 Automatic Urinalysis System Reagent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

MINDRAY DC-70 Pro Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MINDRAY Digital Radiography System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

MINDRAY ePM 12MA Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MINDRAY Z60 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MINDRAY ePM 15C Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MINDRAY DC-39 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 26, 2024

MINDRAY SCCA Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 26, 2024

MINDRAY DC-60S (with X-Insight) Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MINDRAY ePM 12C Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MINDRAY ePM 12A Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MINDRAY BeneFusion SP5 TCI

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

MINDRAY ePM 10A Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2024

MINDRAY ePM 15MA Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2024

MINDRAY BeneFusion SP5 DTCI

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 13, 2024

MINDRAY Rubella Virus IgG (CLIA) Calibrators included

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 12, 2024

MINDRAY Endoscope Camera System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2024

MINDRAY BeneHeart C1A Fully Automatic (Automated External Defibrillator(AED))

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 2, 2024

MINDRAY BeneHeart C2 Fully Automatic (Automated External Defibrillator(AED))

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 2, 2024

MINDRAY Rigid Endoscope

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2024

MINDRAY E3 Estriol (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2024

MINDRAY Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method) with Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2024

MINDRAY LS LYSE

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2024

MINDRAY G6PD Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2024

MINDRAY BS-800 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

MINDRAY ASO/CRP/RF Triple Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2024

MINDRAY ADA Adenosine Deaminase Kit (Enzymatic Colorimetric Method) with Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 6, 2024

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2024

MINDRAY Medical Supply Unit

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2024

MINDRAY UIBC Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2024

MINDRAY CK-MB Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2024

MINDRAY 5'-NT Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2024

MINDRAY RF II Rheumatoid Factor Kit (Immunoturbidimetric Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 27, 2024

MINDRAY ApoA1 Apolipoprotein A1 Kit (Turbidimetry Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

MINDRAY TPUC Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2024

MINDRAY ASO II Antistreptolysin O Kit (Latex Immunoturbidimetric Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

MINDRAY ASO II Antistreptolysin O Kit (Latex Immunoturbidimetric Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 21, 2024

MINDRAY Prealbumin Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

MINDRAY MALB Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

MINDRAY FER Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 17, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

MINDRAY HS-CRP High Sensitivity C-Reactive Protein Kit (Particle-enhanced Immunoturbidimetric Assay Method) with Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

MINDRAY Total Protein in Urine/CSF (TPUC) Kit (Pyrogallol Red-Molybdate Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

MINDRAY Multimmun Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

MINDRAY ADA Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

MINDRAY Antistreptolysin "O" Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 13, 2024

MINDRAY Hyaluronic acid (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2024

MINDRAY Anti-thyroid Antibodies Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2024

MINDRAY 5'-NT 5'-Nucleotidase Kit (Enzymatic Colorimetric Method) with Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 9, 2024

MINDRAY HCY Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MINDRAY D-Dimer Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MINDRAY ADA Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MINDRAY Cystatin C Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MINDRAY LED Surgical Lights

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 2, 2024

MINDRAY BS-240Pro Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 29, 2024

MINDRAY eGateway System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

MINDRAY Anti-Thyrotropin Receptor Antibody (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

MINDRAY Testosterone Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2024

MINDRAY CA242 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 19, 2024

MINDRAY ePM 15 Patient monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2024

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 16, 2024

MINDRAY Probe Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 5, 2024

MINDRAY HE4 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2024

MINDRAY ProGRP Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2024

MINDRAY DC-60 Pro (X-Insight) Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 2, 2024

MINDRAY FPSA Free Prostate Specific Antigen (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 27, 2024

MINDRAY CAL 8000 Auto Sample Processing System and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 25, 2024

MINDRAY NT-proBNP N-Terminal pro B-type natriuretic peptide (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

MINDRAY Progesterone Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

MINDRAY HBeAg Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

MINDRAY BC-30 Auto Hematology Analyzer

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2024

MINDRAY PIIINP N-terminal Peptide of Procollagen Type III (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

MINDRAY NT-proBNP Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2024

MINDRAY NT-proBNP Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2024

MINDRAY BC-5380 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2024

MINDRAY AF-300 Automated Identification and Susceptibility Testing System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

MINDRAY AP-100 Automated Dosing System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

MINDRAY TDR STR-96 Streptococcus ID&AST Kit

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 4, 2024

MINDRAY TDR-X240 Automated Blood Culture System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 4, 2024

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 4, 2024

MINDRAY BC-30s Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2024

MINDRAY Color Doppler Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 29, 2024

MINDRAY hs-cTnl Control (L3)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 26, 2024

MINDRAY HIV Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

MINDRAY TDR STAPH-96

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

MINDRAY TDR-X060 Automated Blood Culture System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

MHINA M-58LEO(II) Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

MINDRAY TDR-X120 Automated Blood Culture System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 25, 2024

MINDRAY Anti-HCV Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

MINDRAY TDR YEAST-96

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

MINDRAY Anti-HCV Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2024

MINDRAY M-58LEO (I) Bright

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2024

MINDRAY TDR ONE-96

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 19, 2024

MINDRAY BA-88A Semi-Auto Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 17, 2024

MINDRAY Metabolic Multi Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2024

MINDRAY BC-20s Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2024

MINDRAY TDR NH-96 Neisseria/Haemophilus ID&AST Kit

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2024

MINDRAY TDR-300B PLUS Microorganism Analysis System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 2, 2024

MINDRAY M-53D Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

MINDRAY M-6LN Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

MINDRAY 25-OH-Vitamin D Total Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2024

MINDRAY M-58 Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2024

MINDRAY BC-20 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2024

MINDRAY Sample Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 31, 2024

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 24, 2024

MINDRAY TDR NF-96

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2024

MINDRAY M-6DR Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2024

MINDRAY TDR Resin Peds Culture Bottle

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2024

MINDRAY TDR Resin Anaerobic Culture Bottle

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2024

MINDRAY HBeAg Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2024

MINDRAY TDR Resin Aerobic Culture Bottle

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 14, 2024

MAZY M-6LH LYSE

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2024

MINDRAY TDR-Z200 Microbe Turbidimeter

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 9, 2024

MINDRAY PCT Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2024

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 5, 2024

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 4, 2024

MINDRAY Immunoassay Multi Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2024

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

MINDRAY Bacterial McFarland Standard

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2023

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 27, 2023

MINDRAY M-30R Rinse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 22, 2023

MINDRAY M-52LH Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

MINDRAY DS Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2023

MINDRAY Gastritis Multi Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

MINDRAY M-52D Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

MINDRAY Hemoglobin A1c Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

MINDRAY M-53 Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2023

MINDRAY C-Reactive Protein (CRP) Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

MINDRAY M-53 LEO (II) Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

MINDRAY M-53 LEO (I) Bright

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2023

MINDRAY Hemoglobin A1C Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2023

MINDRAY M-30E E-Z Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 14, 2023

MINDRAY M-52DIFF Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

MINDRAY M-6LD Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

MINDRAY M-30D Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

MINDRAY Gastritis Multi Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2023

MINDRAY M-68LB Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2023

MINDRAY M-58LH Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

MINDRAY ESR Solution Reagent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2023

MINDRAY M-58 LBA Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

MINDRAY Eluent B

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY C-Peptide Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY Hemolysis Solution

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY M-30CFL Bright

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY M-10CFL Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY M-20CFL Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY Eluent A

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

MINDRAY Electrosurgical Platform

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2023

MINDRAY M-68FN Dye

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2023

MINDRAY M-6FD Dye

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2023

MINDRAY Electrosurgical Platform

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2023

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2023

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2023

MINDRAY Insulin Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2023

SHANGHAI LONG ISLAND Antithrombin III (AT-III) Assay Kit (Chromogenic Substrate Method)

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 15, 2023

MINDRAY Pepsinogen I (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

MINDRAY PG II Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

CALIBRATORS ARE A PG

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

MINDRAY CA72-4 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

MINDRAY Chloride Electrode (Cl-)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

MINDRAY Calcitonin (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

MINDRAY D-D Cal D-Dimer Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

MINDRAY D-D with D-Dimer Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2023

MINDRAY Rigid Endoscope

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

MINDRAY Lipoprotein (a) Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

MINDRAY Semirigid Operating Instruments

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2023

MINDRAY IL-6 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 10, 2023

MINDRAY Coagulation Control (Level 1)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

MINDRAY Operating Table

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2023

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 22, 2023

MINDRAY Antibody to Hepatitis B Core Antigen (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 21, 2023

MINDRAY Anti-HBe Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 18, 2023

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2023

MINDRAY CD80 Detergent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2023

MINDRAY Anti-HBc Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2023

MINDRAY NSE Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

MINDRAY Anti-HBc Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

MINDRAY Lipoprotein (a) Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

SHANGHAI LONG ISLAND Fibrinogen Assay Kit (FIB)

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

SHANGHAI LONG ISLAND D-Dimer Assay Kit

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2023

MINDRAY Tumor Marker Multi Control II (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 14, 2023

MINDRAY Lp(a) II Lipoprotein (a) Kit (Latex Immunoturbidimetric Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

MINDRAY C3100 Auto Coagulation Analyzer

Manufacturer:

BEIJING MINDRAY MEDICAL INSTRUMENT CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 11, 2023

MINDRAY U1 Endoscope Camera System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

MINDRAY C3510 Auto Coagulation Analyzer

Manufacturer:

BEIJING MINDRAY MEDICAL INSTRUMENT CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 7, 2023

MINDRAY Cortisol Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2023

MINDRAY DIGIT 21-1 (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 4, 2023

MINDRAY HS-CRP Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2023

MINDRAY C2000-2 Semi-Auto Coagulation Analyzer

Manufacturer:

BEIJING MINDRAY MEDICAL INSTRUMENT CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2023

MINDRAY Cortisol (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 1, 2023

MINDRAY BS-430 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2023

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2023

MINDRAY Hip Prosthesis

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2023

MINDRAY Operating Table

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 18, 2023

MINDRAY Lipase Kit (Enzymatic Colorimetric Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 18, 2023

MINDRAY Non-Sterile Spinal Internal Fixation Systems

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 14, 2023

MINDRAY Operating Table

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 11, 2023

MINDRAY Sodium Electrode (Na+)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

SHANGHAI LONG ISLAND Thrombin Time Reagent (TT)

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

MINDRAY Potassium Electrode (K+)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

MINDRAY HS-CRP High Sensitivity C-reaction Protein Kit (Particle-enhanced Immunoturbidimetric Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 22, 2023

MINDRAY Color Doppler Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2023

MINDRAY Digital Ultrasonic Diagnostic Imaging System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2023

MINDRAY Digital Ultrasonic Diagnostic Imaging System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2023

SHANGHAI LONG ISLAND Calcium Chloride Solution

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2023

SHANGHAI LONG ISLAND Activated Partial Thromboplastin Time (APTT) Reagent (Ellagic Acid)

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2023

SHANGHAI LONG ISLAND Prothrombin Time Reagent (PT)

Manufacturer:

SHANGHAI LONG ISLAND BIOTEC,CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2023

MINDRAY MALB Microalbumin Kit (Immunoturbidimetric Assay Method) Plus Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 5, 2023

MINDRAY MALB Microalbumin Kit (Immunoturbidimetric Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

MINDRAY Diagnostic Ultrasound System DC-60 Exp (with X-Insight)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

MINDRAY Disposable Trocars

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2023

MINDRAY BeneHeart R3 Electrocardiograph

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2023

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 27, 2023

MINDRAY Digital Ultrasonic Diagnostic Imaging System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2023

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2023

MINDRAY Portable Color Doppler Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

MINDRAY BeneFusion VP5

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

MINDRAY WATO EX-55 Anesthesia Machine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2023

MINDRAY Infusion Pump

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2023

MINDRAY BeneFusion SP1

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2023

MINDRAY WATO EX-20 Anesthesia Machine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

MINDRAY WATO EX-65 Anesthesia Machine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

MINDRAY WATO EX-30 Anesthesia Machine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 8, 2023

MINDRAY Total Protein in Urine/CSF (TPUC) Kit (Pyrogallol Red-Molybdate Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2023

MINDRAY T3 Total Triiodothyronine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

MINDRAY Probe Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 1, 2023

MINDRAY BS-360E Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

MINDRAY Insufflator

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2023

MINDRAY HB300L-T Endoscope Light Source

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

MINDRAY BC-5150 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

MINDRAY Cholinesterase (CHE) Kit (DGKC Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 10, 2023

MINDRAY BC-5000 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

MINDRAY U1-T Endoscope Camera System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2023

MINDRAY ApoB Apolipoprotein B Kit (Turbidimetry Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

MINDRAY HD3-T Endoscope Camera System

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2023

MINDRAY Tumor Marker Multi Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 24, 2023

MINDRAY ApoA1 Apolipoprotein A1 Kit (Turbidimetry Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 24, 2023

MINDRAY BC-10 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2023

MINDRAY HB200L Endoscope Light Source

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 21, 2023

MINDRAY BC-5D Hematology Controls

Manufacturer:

R&D SYSTEMS,INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2023

MINDRAY BNP Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 20, 2023

MINDRAY BC-5130 Auto Hematology Analyzer and accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 16, 2023

MINDRAY BC-5140 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 16, 2023

MINDRAY HD3 Endoscope Camera System

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 16, 2023

MINDRAY HB300L-S Endoscope Light Source

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2023

MINDRAY U1-S Endoscope Camera System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2023

MINDRAY CA15-3 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 13, 2023

MINDRAY Bil-T Bilirubin Total Kit (VOX Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

MINDRAY HB300L Endoscope Light Source

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

MINDRAY HD3-S Endoscope Camera System

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

MINDRAY Specific Proteins Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2023

MINDRAY Lipoprotein (a) Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 30, 2023

MINDRAY Antibody to thyroid peroxidase (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY C-Reaction Protein (CRP) Kit (Latex Particle-Enhanced Immunonephelometry Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY rT3 Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY Reverse Triiodothyronine (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY Anti-Tg Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY Folate Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY rT3 Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY AMH Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

MINDRAY Anti-thyroid Antibodies Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

MINDRAY Anti-TPO Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

MINDRAY Anti-thyroid Antibodies Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

MINDRAY rT3 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 21, 2022

MINDRAY HS-CRP Kit (Particle-enhanced Immunoturbidimetric Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 20, 2022

MINDRAY AMH Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

MINDRAY Folate (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2022

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 8, 2022

MINDRAY Hybase 6100 Operating Table

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2022

MINDRAY Syringe Pump

Manufacturer:

SHENZHEN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2022

MINDRAY BeneVision Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

CARETIUM Urine Diluent

Manufacturer:

CARETIUM MEDICAL INSTRUMENTS CO.,LIMITED

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 25, 2022

MINDRAY Anesthetic Vaporizer

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 25, 2022

Caretium ISE Reagent Pack

Manufacturer:

CARETIUM MEDICAL INSTRUMENTS CO.,LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 3, 2022

MINDRAY HCG Total B Human Chorionic Gonadotropin (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

MINDRAY CL-900i Chemiluminescence Immunoassay Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

OPTCLA Reusable Trocar

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 27, 2022

OPTCLA Reusable Applier

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 26, 2022

MINDRAY Cl- Chlorine Electrode

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2022

MINDRAY K+ Potassium Electrode

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2022

MINDRAY Reusable Laparoscopic Instruments, Reusable Applier

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 16, 2022

MINDRAY Disposable Electrode Surgical Instruments

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 14, 2022

MINDRAY Disposable Endoscopy Surgical Instruments 'Disposable Veress Needle'

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2022

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 8, 2022

MINDRAY Na+ Sodium Electrode

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

MINDRAY Disposable Electrode Surgical Instruments (Coagulation Electrode)

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 23, 2022

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2022

MINDRAY Electrocardiograph

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2022

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2022

MINDRAY BeneVision N17

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2022

MINDRAY Reusable Laparoscopic Instruments, Reusable Needle Holder

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 16, 2022

MINDRAY Z.ONE PRO Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2022

MINDRAY Vital Signs Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2022

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2022

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 5, 2022

MINDRAY BeneVision Central Monitoring System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2022

MINDRAY SC-120 Slide Maker & Stainer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2022

MINDRAY Anesthesia Machine A7

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2022

MINDRAY Wash Buffer

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 26, 2022

MINDRAY Mobile Radiography System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 26, 2022

MINDRAY LED Surgical Light (Mobile)

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2022

MINDRAY BC-6000 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2022

MINDRAY M-6FN DYE

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 19, 2022

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 18, 2022

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 18, 2022

MINDRAY BS-620M Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2022

MINDRAY T4 Total Thyroxine (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

MINDRAY MH Hip Joint Instrument Upgrade Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 30, 2022

MINDRAY FT4 Free Thyroxine (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 29, 2022

MINDRAY FT3 Free Triiodothyronine (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 29, 2022

MINDRAY CK Creatine Kinase Kit (IFCC Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 28, 2022

MINDRAY HbA1c Hemoglobin A1c Kit (Enzymatic Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2022

MINDRAY Free T3 Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2022

MINDRAY Magnesium Kit (Xylidyl Blue Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2022

MINDRAY CK-MB Creatine Kinase-MB Kit (IFCC Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2022

MINDRAY BC-700 [B] Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MINDRAY CRP C-Reactive Protein Kit (Turbidimetry Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MINDRAY Phosphorus Kit (Phosphomolybdate Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MINDRAY ADA Adenosine Deaminase Kit (Enzymatic Colorimetric Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MINDRAY GGT Gamma-Glutamyltransferase Kit (Szasz Method/IFFC Stand)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2022

MINDRAY BC-720 [R] Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

MINDRAY Ca Calcium Kit (Arsenazo III Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

MINDRAY Iron (Fe) Kit (Colorimetric Assay)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

MINDRAY BC-760 [R] Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2022

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2022

MINDRAY Patella Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 6, 2022

MINDRAY Femoral Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 24, 2022

MINDRAY Cemented Stem Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 11, 2022

MINDRAY NEOS Revision Stem Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

MINDRAY Tapered Stem Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

MINDRAY Wedge-shaped Stem Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

MINDRAY NEOS Primary Stem Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2022

MINDRAY MC-80 Automated Digital Cell Morphology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

MINDRAY Bipolar Trial Tray

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 27, 2022

MINDRAY Interbody Fusion Cage

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2022

MINDRAY A9 Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2022

MINDRAY Knee Prosthesis

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2022

MINDRAY A8 Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 23, 2022

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 16, 2022

MINDRAY TDR NF-96

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

MINDRAY LED Examination Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 8, 2022

MINDRAY SARS-CoV-2 NT Antibody Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2022

MINDRAY TDR STR-96

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2022

MINDRAY Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Antibody (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2022

MINDRAY SARS-CoV-2 NT Antibody Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2022

MINDRAY Severe Acute Respiratory Syndrome Coronavirus 2 S-RBD IgG (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2022

MINDRAY SARS-CoV-2 S-RBD IgG Antibody Control (L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2022

MINDRAY SARS-CoV-2 S-RBD IgG Antibody Control (H)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 14, 2022

MINDRAY TDR YEAST-64

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2022

MINDRAY TDR STR-64

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2022

MINDRAY TDR STAPH-64

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 8, 2022

MINDRAY TDR Resin Aerobic Culture Bottle

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 19, 2022

MINDRAY TDR Resin Peds Culture Bottle

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 17, 2022

MINDRAY TDR Resin Anaerobic Culture Bottle

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 14, 2022

MINDRAY Vital Signs Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2021

MINDRAY Vital Signs Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 28, 2021

MINDRAY LED Examination & Treatment Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 26, 2021

MINDRAY TDR-J100 Automated Dosing System and Accessories

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 25, 2021

MINDRAY TDR-Z200 Microbe Turbidimeter

Manufacturer:

HUNAN MINDRAY MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 25, 2021

MINDRAY Defibrillator/Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Dec 23, 2021

MINDRAY Ventilator SV350

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2021

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2021

MINDRAY NB350 Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2021

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2021

MINDRAY NB300 Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2021

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 15, 2021

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2021

MINDRAY MR-VA 2.7 Special Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 9, 2021

MINDRAY BS-480 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2021

MINDRAY CMF Instrument Set II

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 9, 2021

MINDRAY 1.5mm Mini Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY PLIF Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY Proximal Femur LISS Instrument Special Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY Anterior Cervical Plate Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY Proximal Femur LISS Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY BS-220E Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2021

MINDRAY BS-200E Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 8, 2021

MINDRAY GSS6.0 System Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY Extraction Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 8, 2021

MINDRAY Universal External Fixation Systems

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2021

MINDRAY Substrate Solution

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 7, 2021

MINDRAY Proximal Humeral Plate Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2021

MINDRAY 6.5 mm Locking Screw Instruments Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 6, 2021

MINDRAY 6.5/7.5mm Cannulated Screw Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2021

MINDRAY MR-VA Distal Lateral Humeral Plate Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2021

MINDRAY MR-VA Anterior Clavicle Plate Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2021

MINDRAY 4.5mm Cannulated Screw Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2021

MINDRAY 3.0/3.5mm Cannulated Screw Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 5, 2021

MINDRAY SC-CAL PLUS Hematology Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2021

MINDRAY BC-6D Hematology Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2021

MINDRAY BC-RET Hematology Control (H,N,L)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2021

MINDRAY Large Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 29, 2021

MINDRAY Femoral Nail Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 29, 2021

MINDRAY Large Locking Instrument Set (MR)

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 26, 2021

MINDRAY MR-VA Distal Medial Humeral Plate Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 26, 2021

MINDRAY Small Fragment Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 26, 2021

MINDRAY MR-VA Olecranon Plate Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 26, 2021

MINDRAY MR-VA Distal Radius Instrument Special Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 26, 2021

MINDRAY Anti-TP Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2021

MINDRAY Anti-HCV Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2021

MINDRAY Mini Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 19, 2021

MINDRAY 2.7mm Mini Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 19, 2021

MINDRAY 2.7mm Mini Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 19, 2021

MINDRAY BIL-D Bilirubin Direct Kit (VOX Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2021

MINDRAY Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2021

MINDRAY Mini Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2021

MINDRAY 2.0mm Mini Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 16, 2021

MINDRAY MR-IM Femoral Nail Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY External Fixation Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY MR-IM Femoral Nail (short) Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY Small Locking Instrument Set (MR)

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY Small Locking Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY Distal Femur LISS Instrument Special Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY OSTO Knee System Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY Proximal Tibia LISS Instrument Special Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY Tibial Nail (cannulated) Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 15, 2021

MINDRAY Reconstruction Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 12, 2021

MINDRAY Digital Radiography System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 11, 2021

MINDRAY PFNA Instrument Set

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 10, 2021

MINDRAY CL-6000i Chemiluminesence Immunoassay system and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2021

OPTCLA Disposable Electrode Surgical Instruments

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2021

MINDRAY HIV Ag/Ab Positive Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2021

MINDRAY HIV Ag/Ab Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2021

MINDRAY D-Dimer Kit (Particle-enhanced Immunoturbidimetric Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 20, 2021

OPTCLA Disposable Electrode Surgical and Intruments (Coagulation Electrode)

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2021

MINDRAY HBsAg Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2021

MINDRAY Medical Supply Unit HyPort 3000 with Accessories

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2021

MINDRAY HBsAg Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2021

MINDRAY HBsAg Positive Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2021

MINDRAY Disposable Suction and Irrigation Tubes

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2021

MINDRAY Medical Supply Unit HyPort R80T

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

MINDRAY Medical Supply Unit HyPort R80

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

MINDRAY Medical Supply Unit HyPort 6000

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

MINDRAY Medical Supply Unit HyPort B30

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

OPTCLA Disposable Veress Needle

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 2, 2021

MINDRAY Non-Sterile Intramedullary Nailing Systems

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 24, 2021

MINDRAY SARS-CoV-2 IgM Positive Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 19, 2021

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 18, 2021

MINDRAY SARS-CoV-2 IgM/IgG Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 16, 2021

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2021

MINDRAY SARS-CoV-2 IgG Positive control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2021

MINDRAY Diagnostic Ultrasound System Nuewa R9 Pro with Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 10, 2021

MINDRAY Diagnostic Ultrasound System Nuewa I9S with Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 9, 2021

MINDRAY Non-Sterile Bone Plates

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2021

MINDRAY Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method) plus Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2021

MINDRAY Ferritin Kit (Particle-enhanced Immunoturbidimetric Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 30, 2021

MINDRAY CysC II Cystatin C Kit (Latex Immunoturbidimetric Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

MINDRAY Diagnostic Ultrasound System Nuewa R9 Exp with Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2021

MINDRAY Diagnostic Ultrasound System Nuewa R9 with Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2021

MINDRAY Z60 Expert Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

MINDRAY Non-Sterile Bone Screws_2

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 13, 2021

MINDRAY HbA1c Hemoglobin A1c Kit (Enzymatic Assay Method) โ€“ Twin test

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 13, 2021

MINDRAY Non-Sterile Bone Screws

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 13, 2021

MINDRAY Non-Sterile Bone Plates_3

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2021

MINDRAY Non-Sterile Bone Plates_2

Manufacturer:

WUHAN MINDRAY SCIENTIFIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2021

OPTCLA Reusable Needle Holder

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 1, 2021

MINDRAY CL-1200i Chemiluminescence Immunoassay Analyzer

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 21, 2021

MINDRAY uMEC10 Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2021

MINDRAY iMEC 15 Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2021

MINDRAY iMEC 15S Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 20, 2021

MINDRAY TC Total Cholesterol Kit (CHOD-POD Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

MINDRAY HbA1c Hemoglobin A1c Kit (Enzymatic Assay Method) โ€“ Twin test

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2021

MINDRAY BC-3600 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD..

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2021

MINDRAY M-58LH Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

MINDRAY HbA1c Hemoglobin A1c Kit (Enzymatic Assay Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

MINDRAY GLU Glucose Kit (HK Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2021

MINDRAY GLU Glucose Kit (GOD-POD Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 10, 2021

MINDRAY Bil-D Bilirubin Direct Kit (DSA Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2021

MINDRAY UMEC 12 Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

MINDRAY M-68LN Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

MINDRAY M-68LD Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 31, 2021

MINDRAY UA-600 Urine Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 24, 2021

M-58D Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2021

MINDRAY M-18R Rinse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2021

MINDRAY TG Triglycerides Kit (GPO-POD Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2021

MINDRAY BENEHEART D2 Defibrillator / Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 17, 2021

MINDRAY BENEHEART D6 Defibrillator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

May 17, 2021

MINDRAY M-68FR Dye

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 14, 2021

MINDRAY M-68FN Dye

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 11, 2021

MINDRAY Bil-T Bilirubin Total Kit (DSA Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2021

MINDRAY M-68FD Dye

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 9, 2021

MINDRAY M-68DR Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2021

MINDRAY UA-600T Urine Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2021

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

MINDRAY Color Doppler Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

MINDRAY Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 5, 2021

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICSC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

MINDRAY BC-6800 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

MINDRAY UA Uric Acid Kit (Uricase-Peroxidase Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 4, 2021

MINDRAY Anti-TP Negative Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 1, 2021

MINDRAY ANTI-TP Positive Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 1, 2021

MINDRAY BS-800M Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 26, 2021

MINDRAY BeneView T6 Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

MINDRAY M-18D Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.,CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

MINDRAY Ventilator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 21, 2021

MINDRAY B30 Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 16, 2021

OPTCLA Disposable Trocars

Manufacturer:

HANGZHOU OPTCLA MEDICAL INSTRUMENT CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2021

MINDRAY M-18E E-Z Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 12, 2021

MINDRAY M6 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2021

MINDRAY Color Doppler Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 12, 2021

MINDRAY M-18CFL Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

MINDRAY BS-240 Clinical Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 7, 2021

MINDRAY B55 Hematology Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2021

MINDRAY HIV Antigen and Antibodies to Human Immunodeficiency Virus (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Mar 20, 2021

MINDRAY DC-32 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2021

MINDRAY DC-28 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONIC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 18, 2021

MINDRAY SARS-COV-2 IgM(CLIA) Severe Acute Respiratory Syndrome Coronavirus 2 IgM (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 3, 2021

MINDRAY Urea Kit (Urease-GLDH, UV Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

MINDRAY M-68DS Diluent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 25, 2021

MINDRAY LDL-Cholesterol Kit (Direct Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 22, 2021

MINDRAY Sample Processing System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 19, 2021

MINDRAY CD80 Detergent

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 18, 2021

MINDRAY ALT Alanine Aminotransferase Kit (IFFC Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2021

MINDRAY AST Aspartate Aminotransferase Kit (IFCC Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.CO.LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2021

MINDRAY Alkaline Phosphatase Kit (IFCC Modified Method )

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2021

MINDRAY SARS-COV-2 IgG(CLIA) Severe Acute Respiratory Syndrome Coronavirus 2 IgG (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN BIO-MEDICAL ELECTRONICS CO., LTD. P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 18, 2020

MINDRAY WATO Anesthesia Machine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

MINDRAY WATO EX-65 Pro Anesthesia Machine

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 17, 2020

MINDRAY DC-30 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 3, 2020

MINDRAY Portable Color Doppler Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 1, 2020

MINDRAY MX7 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2020

MINDRAY Digital Ultrasonic Diagnostic Imaging System

Manufacturer:

SHENZHEN MINDRAY BIO-MINDRAY ELECTRONICS CO., LTD., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 26, 2020

MINDRAY Color Doppler Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2020

MINDRAY CL-2000i Chemiluminescence Immunoassay System and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

MINDRAY DC-30 Diagnostic Ultrasound System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2020

MINDRAY CREA Creatinine Kit (Sarcosine Oxidase Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2020

MINDRAY C-reactive Protein Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2020

MINDRAY M-18P Probe Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 26, 2020

MINDRAY M-30P Probe Cleanser

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 23, 2020

MINDRAY CL-960i Chemiluminescence Immunoassay system

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2020

MINDRAY BC-21 Auto Hematology Analyzer

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2020

MINDRAY BC-5390CRP Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 12, 2020

MINDRAY C-reactive Protein (CRP) Calibrator

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 28, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 22, 2020

MINDRAY Total ฮฒ HCG Calibrators

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 1, 2020

MINDRAY Total ฮฒ Human Chorionic Gonadotropin (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2020

MINDRAY SC-CAL PLUS Calibrator

Manufacturer:

R&D SYSTEMS INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 30, 2020

MINDRAY Patient Monitor

Manufacturer:

SHENZEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 10, 2020

MINDRAY M-68LH Lyse

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 25, 2020

MINDRAY LDH Lactate Dehydrogenase Kit (IFCC Method)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2020

MINDRAY UIBC Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2020

MINDRAY BS-600 Chemistry Analyzer and accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 30, 2019

MINDRAY ADA Control

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2019

MINDRAY Testosterone (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 5, 2019

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

MINDRAY Progesterone (CLIA)

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2019

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS., CO., P.R.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 29, 2019

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2019

MINDRAY LED Surgical Light

Manufacturer:

NANJING MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 17, 2019

A5 Anesthesia System

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 17, 2019

MINDRAY BS-120 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

MINDRAY BS-200 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 7, 2019

MINDRAY Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2019

MINDRAY BC-2800 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2019

MINDRAY BS-380 Chemistry Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 19, 2019

MINDRAY BeneVision BP10 NIBP Module

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 17, 2019

MINDRAY BC-5300 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

MINDRAY BC-3000 Plus Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2019

MINDRAY BC-1800 Auto Hematology Analyzer and Accessories

Manufacturer:

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2019

Data sourced from BPOM (Badan Pengawas Obat dan Makanan), Indonesia.

Last updated: December 2025