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PT. FAITHFUL MEDICAL GRACE

Authorized Representative in Indonesia

Mitra Sunter Boulevard Blok B No. 39, Jl. Yos Sudarso Kav. 89 Kel. Sunter Jaya, Kec. Tanjung Priok, Jakarta Utara
581 Products Represented
71 Manufacturers
Total Products
581
Manufacturers
71
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
72 products
12.4%
Kelas Resiko : B
374 products
64.4%
Kelas Resiko : C
128 products
22.0%
Kelas Resiko : D
7 products
1.2%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (581)
Complete portfolio registered with BPOM

SM MALB Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

SM Multi Control for Clinical Chemistry Analyzer Level 1

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

SM TB-DCA Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 7, 2025

SM DB-DCA Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 5, 2025

SM – 700 Automatic Chemistry Analyzer

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2025

SM FC-73 Flow Cytometer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

SM Control Hematology Analyzer for 3 Diff

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 15, 2025

SM Control Hematology Analyzer for 5 Diff

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2025

SM Control Hematology Analyzer for 5 Diff (Normal Level)

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 6, 2025

SM 420 Automatic Chemistry Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2024

Drawray iStar – Insulin

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

Drawray iStar – C-Peptide

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 16, 2024

Drawray iStar - SAA

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2024

SM Alkaline Detergent

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2024

Array Molarray Real-Time Quantitative Thermal Cycler and Accessories

Manufacturer:

SUZHOU MOLARRAY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 4, 2024

Cornley Li+ Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

CORNLEY Electrolytes Quality Control (Medium Level)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

SM Reticulocyte Control for Hematology Analyzer Level 2

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2024

SM Reticulocyte Control for Hematology Analyzer Level 1

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

CORNLEY Electrolytes Quality Control (High Level)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

SM SETIA MEDIKA-5D-110 Auto Hematology 5-Part-Diff Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

CORNLEY TH Electrode for use with BGE measuring system

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 9, 2024

DRAWRAY iStar - CHI3L1

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2024

CORNLEY TCO2 Reaction Solution

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

CORNLEY Electrolytes Quality Control

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

CORNLEY Selectivity Coefficient Calibrator

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2024

CORNLEY Refill Solution (for ISE Electrode)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

CORNLEY Refill Solution (for Reference Electrode)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

CORNLEY Refill Solution (for Li+ Electrode)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 9, 2024

SM-230 Automatic Chemistry Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

CORNLEY Calibration Standard Solution

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 3, 2024

DRAWRAY Sample Diluent G-1

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 2, 2024

Drawray Sample Diluent H-1

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

SM UA Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

DRAWRAY Sample Diluent D-1

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2024

CORNLEY K-LITE 8G Electrolyte Analyzer and Accessories

Manufacturer:

Meizhou Cornley Hi-Tech , Co., Ltd.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2024

SM CR-OX REAGENT KIT

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2024

SM α -AMY Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2024

SM CK-NAC REAGENT KIT

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 22, 2024

SM HCY Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

SM – 330 Automatic Chemistry Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

SM CHOLESTEROL REAGENT KIT

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2024

BIL MICRO METER AUTO-3 and Accessories

Manufacturer:

FUCHU GIKEN INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 19, 2024

ZHUHAI Aerobic Blood Culture Bottle

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

DL Automated Sampling Instrument and Accessories

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

ZHUHAI DL-BT 64 Auto Blood Culture Detection System and Accessories

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 19, 2024

SM TP Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

SM Cys-C Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

SM GLU-OX Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 13, 2024

SM Calibrator Hematology Analyzer

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2024

SM TG Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

SM LDH Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 8, 2024

SM HDL-C Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

SM ALB Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

SM LDL-C Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 31, 2024

DRAWRAY Sample Diluent B-1

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

SM BUN Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

SM ALP Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

SM ALT Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

SM AST Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

SM Reticulocyte Control for Hematology Analyzer

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2024

SM CHE Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 7, 2024

SM Control Hematology Analyzer

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

SM Lyse

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

SM SHEATH

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

SM Diluent

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 3, 2024

SM Urine Control QC-11P

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2024

SM Urine Control QC-14P

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 27, 2024

SM Urine Sediment Control Level 3

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 25, 2024

SM Urine Control QC-10P

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

SM Urine Sediment Control Level 2

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

SM Urine Sediment Control Level 1

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

SM GGT Reagent Kit

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

SM UA-60 Urine Analyzer and accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 14, 2024

SM Staining Solution

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 10, 2024

SM 5D-BF Automatic Hematology 5 Diff Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2024

SM 14P Urine Reagent Strip

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2024

CORNLEY K-LITE 8B Electrolyte Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2024

SM DETERGENT

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2024

SM PROBE CLEANER

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2024

SM Urine Sediment Calibrator

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2024

SM LYTIC REAGENT

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

SM-300 Semi-Automatic Urine Analyzer And Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 21, 2024

SM 10P Urine Reagent Strip

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2024

SM 11P Urine Reagent Strip

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2024

SM-308 Semi-Automatic Chemistry Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

SM-660 RET Automated Hematology 5-Diff Analyzer And Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

AIKANG Coombs Card (9 Columns)

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 14, 2024

SM S-600 Urine Analyzer and Accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 14, 2024

SM – 3D Automated Hematology Analyzer and accessories

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

CORNLEY K-LITE 8F Electrolyte Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

SM Diluent

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

AIKANG Coombs Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2024

SM DETERGENT C

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 26, 2024

AIKANG LISS

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 23, 2024

SM DETERGENT A

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 23, 2024

SM DETERGENT

Manufacturer:

URIT MEDICAL ELECTRONIC CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 23, 2024

DRAWRAY iStar -ICA

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2024

CORNLEY K-LITE 8F Electrolyte Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 22, 2024

Drawery Lining -Krupp

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 4, 2024

Drawray iStar-Gastrin-17

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

Easter-SBG in the drawer

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 28, 2024

AIKANG Antibody Diluent

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

DRAWRAY iStar-GADA

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

AIKANG Cell Reservation Solution

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 25, 2024

LITUO Cell Preservative Solution (Gyn)

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 19, 2024

DRAWRAY iStar -IA-2A

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

LITUO Nucleic Acid Detection Kit For High-Risk Human Papillomavirus (Typing) (PCR-Fluorescent Probing)

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2024

AIKANG ABO/Rh and Reverse Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

AIKANG ABO/RHD and Reverse Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

AIKANG ABO/RHD CARD

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

ALTA Lipid Test Strip

Manufacturer:

BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

Drawere Lining -Ummah

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

AIKANG ASH/RH CARD

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

LITUO Nucleic Acid Detection Kit For High-Risk Human Papillomavirus (PCR-Fluorescent Probing)

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 13, 2024

AIKANG Neutral Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2024

AIKANG ABO CARD

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 5, 2024

AIKANG RH CARD

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 4, 2024

Drawery Lining – Anhabin B

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 29, 2024

LITUO Nucleic Acid Extraction Reagent (Magnetic Bead) - Plate

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 29, 2024

LITUO Nucleic Acid Extraction Reagent (Magnetic Bead) - Kit

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 29, 2024

Easter-High Sensitive Troponin-E in Drawer

Manufacturer:

HUNAN DRAWRAY BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 28, 2024

ALTA Lipid Analyzer and Accessories

Manufacturer:

BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 27, 2024

LITUO Disposable Cervical Sampling Brush

Manufacturer:

TIANJIN ENOU-HEALTH MEDICAL DEVICE TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 12, 2024

LIODETECT TB-ST Tuberculosis Rapid Test

Manufacturer:

LIONEX GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 10, 2024

LIOFERON Tb/LTBI Human IFN- γ ELISA

Manufacturer:

LIONEX GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 10, 2024

LIOFERON Tb/LTBI Human Blood Simulation Tubes

Manufacturer:

LIONEX GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 5, 2024

ADDCARE ADC ELISA 180 Fully Automated ELISA Workstation and Accessories

Manufacturer:

YANTAI ADDCARE BIO-TECH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 22, 2023

YHLO ANA Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

Draw the iStar-ANA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 13, 2023

DRAWRAY iStar-dsDNA IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 7, 2023

DRAWRAY iStar-RF

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2023

YHLO dsDNA IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2023

RENDER Functional Fibrinogen Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 29, 2023

RENDER ITEG2+ Hemostatis Analyzer System and Accessories

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

Render ITEG4+ Hemostatis Analyzer System and Accessories

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

RENDER Platelet Aggregation Assay (Coagulation Method) For IADP2

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 28, 2023

RENDER Platelet Aggregation Assay (Coagulation Method) For IAA2

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2023

DRAWRAY iStar-Anti-CCP

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2023

RENDER Thromboelastogram Control (Control Level I)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

CORNLEY Reference Electrode For use with ISE measuring system

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

CORNLEY Electrolytes Quality Control (Low Level)

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

CORNLEY Electrolytes Quality Control (High Level)

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

Render Thromboelastogram Control (Control Level II)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

CORNLEY pH Electrode for Electrolytes Analyzer

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

RENDER Heparin Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

DRAWRAY iStar- Troponin I

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 21, 2023

RENDER Platelet Aggregation Assay (Coagulation Method) For IADA2

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

RENDER Kaolin Activation Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 17, 2023

DRAWRAY iStar -Pepsinogen I

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

CORNLEY Electrolytes Quality Control

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

DRAWRAY iStar AFP

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

DRAWRAY iStar-Pepsinogen II

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

DIRUI BF-5D DILUENT

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

DIRUI BF-6900CRP Automatic Hematology Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

DIRUI Probe Cleanser I

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 13, 2023

DIRUI BF-6900 Automatic Hematology Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

Drawray iStar -Vitamin B12

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

DRAWRAY iStar- Folate

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

DIRUI BCC-3900 Automatic Hematology Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

AltaGel M Automated Blood Grouping Analyzer and Accessories

Manufacturer:

AIKANG MEDTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 6, 2023

Drawray iStar DEA-S II

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

Drawray iStar-25-OH Vitamin D

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

DIRUI BF-FDO IN Lyse

Manufacturer:

DIRUI INDUSTRIAL, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2023

DRAWRAY iStar-IL-6

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 2, 2023

YHLO ON CONTROL

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2023

DRAWRAY iStar-E2

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

DRAWRAY iStar-FSH

Manufacturer:

SHENZEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

DRAWRAY iStar-Ferritin

Manufacturer:

SHENZEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2023

DRAWRAY iStar-CA15-3

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 30, 2023

DRAWRAY iStar-LH

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2023

YHLO IA-2A Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

RENDER Rapid Activation Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 25, 2023

DIRUI BCC-3600 Hematology Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

DIRUI BF-6500 Automatic Hematology Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2023

RENDER ITEG4 Hemostatis Analyzer System and Accessories

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 19, 2023

DIRUI BF-FDT Lyse

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

DIRUI BF-FDO Lyse

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

DIRUI BCC- 3D Diluent

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

DRAWRAY iStar-Prolactin

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 19, 2023

DIRUI Probe Cleanser

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 16, 2023

DIRUI BCC-3D Lyse

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2023

DRAWRAY iStar-CEA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2023

CORNLEY Reference Electrode For use with BGE measuring system

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2023

DIRUI BCC-3600 Diluent

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

DIRUI BCC - 3600 Lyse

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

DIRUI BF-6500 Lyse (SLS-I)

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2023

YHLO HIV Combo Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 5, 2023

DIRUI BCC-3600 Cleanser

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 5, 2023

DRAWRAY iStar-HCG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 4, 2023

AltaGel S Blood Group Card Centrifuge

Manufacturer:

AIKANG MEDTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

AltaGel I Reagent card incubator

Manufacturer:

AIKANG MEDTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 4, 2023

DRAWRAY iStar-CA125

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2023

DRAWRAY iStar-Progesterone

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

DRAWRAY iStar-Testosterone

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

Drawray iStar-CA19-9

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2023

RENDER ITEG2 Hemostatis Analyzer System and Accessories

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 26, 2023

CORNLEY pH Electrode for Blood Gas Analyzer

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 26, 2023

CORNLEY Ca+ Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2023

YHLO Anti-TP Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 20, 2023

YHLO Cardiolipin IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 14, 2023

CORNLEY Cl- Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

DIRUI CRP

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

YHLO Anti-HCV Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 10, 2023

LITUO Liquid Based Cytology Reagent for Non-Gyn Type I

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2023

LITUO Liquid Based Cytology Reagent For Non-Gyn LTS-3000A&B

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 28, 2023

CORNLEY Na+ Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

CORNLEY K+ Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2023

LITUO Liquid Based Cytology Reagent For Non-Gyn LT-YJ2000

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 22, 2023

Lituo Liquid Based Cytology Reagent for Type IV LTS-YJ1000

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 22, 2023

LITUO Liquid Based Cytology Reagent for Non-Gyn LTS-YJ1000

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 17, 2023

YHLO HBeAg Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

YHLO HBsAg Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

DIRUI MALB

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

YHLO Anti-HBs Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2023

CORNLEY pO2 Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2023

LITUO Cytocentrifuge Smear Processor and Accessories

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2023

LITUO Liquid Based Cytology Reagent

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2023

LITUO Liquid-Based Cytology Smear Processor and Accessories

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 9, 2023

LITUO Liquid Based Cytology Reagent For Type III LTS-3000A & B

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2023

LITUO Liquid Based Cytology Smear Processor and Accesories

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 4, 2023

LITUO Liquid Based Cytology Reagent for Type I

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 1, 2023

ARKRAY Spanclone Anti - A Monoclonal

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 21, 2023

ARKRAY Spanclone Anti - AB Monoclonal

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 20, 2023

ARKRAY Spanclone Anti-D (Rho) Monoclonal IgG + IgM

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 20, 2023

CORNLEY pCO2 Electrode

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2023

ZHUHAI BT60 Auto Blood Culture System and Accessories

Manufacturer:

ZHUHAI DL BIOTECH., CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 7, 2023

DIRUI CK-MB

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

ARKRAY Anti Human Serum (Poly specific) Coomb's Serum

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 30, 2023

ARKRAY Spanclone Anti - B Monoclonal

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 30, 2023

YHLO UNICELL-AMH

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 26, 2023

YHLO UNICELL – HbA1C

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

YHLO UNICELL-cTnI

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

YHLO UNICELL-INHB

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

YHLO UNICELL – PCT/CRP

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

YHLO UNICELL-PCT

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

ARKRAY Stained Salmonella Antigen Set For Widal Test

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

YHLO UNICELL – hsCRP + CRP

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

YHLO UNICELL CK-MB

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

ARKRAY Stained Salmonella Antigen Set For Widal Test (S. typhi H, O, S. para typhi A(H), B(H), A(O), B(O), C(H), dan C(O)

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2023

ARKRAY Signal MF Flow Through Filarial Antibody Spot/Immunodot Test Kit - Device

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

ARKRAY RPR (Rapid Plasma Reagin) Test Kit

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2023

ARKRAY PARAHIT Total ver. 1.0 Rapid Test for P.falciparum and Pan Malarial Species – Dipstick (Tropicalised)

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

ARKRAY ParaHIT Total ver. 1.0 - Rapid Test for P. falciparum and Pan Malarial Species - Device (Tropicalised)

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 9, 2023

CoaDATA 4004 Analyzer and Accessories

Manufacturer:

LABITEC LABOR BIOMEDICAL TECHNOLOGIES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2023

ARKRAY Rheumatoid Factor Latex Test Kit

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2023

ARKRAY Bovine Serum Albumin (22% Solution)

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 7, 2023

CORNLEY Calibration Standard Solution (Cal A)

Manufacturer:

MEIZHOU CORNLEY® HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 5, 2023

YHLO UNICELL-NT-proBNP

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2023

YHLO UNICELL-S Immunofluorescence Reader dan Accessories

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 4, 2023

CORNLEY pCO2 Buffer

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 30, 2023

YHLO iFlash - PG II

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

LABITEC CoaLAB 1000, Fully Automated Coagulation Analyzer and Accessories

Manufacturer:

LABOR BIOMEDICAL TECHNOLOGIES GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 30, 2023

ARKRAY CRP C- Reactive Protein Latex Test Kit

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2023

TECO Coatron X Eco Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION AND TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2023

TECO Coatron X Top Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION AND TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2023

COATRON X Pro Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2023

COATRON A4 Fully Automated Coagulation Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2023

COATRON A6 Fully Automated Coagulation Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2023

ARKRAY ASO (Anti Streptolysin "O') Latex Test Kit

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 23, 2023

ARKRAY MBK G-6PD Qualitative Assay

Manufacturer:

ARKRAY HEALTHCARE PVT., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 22, 2023

CORNLEY pO2 Buffer

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 20, 2023

CoaDATA 504+ Analyzer and Accessories

Manufacturer:

LABITEC LABOR BIOMEDICAL TECHNOLOGIES GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2023

TECO Red D-Dimer

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 10, 2023

RENDER Platelet Aggregation Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2023

TEClot PT-S

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

TECO Tecal N

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTIONS + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

TECO TEControl A

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

CORNLEY Multi-enzyme De-Proteinizer

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 20, 2023

RENDER Platelet Aggregation Assay (Coagulation Method) For IADP1

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

Render Platelet Aggregation Assay (Coagulation Method) For IADA1

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

RENDER Thromboelastogram Control Level II

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

RENDER Kaolin Activation Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

TEClot APTT-S

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 20, 2023

TECO TEControl N

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 20, 2023

TEClot PT-B Kit

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 18, 2023

TECO Teclot TT

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

RENDER Thromboelastogram Control Level I

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

YHLO iFlash - AFP

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

CORNLEY Blood Gas Quality Control High Level

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 3, 2023

TECal DD

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 31, 2023

TECO Blue D-Dimer LC

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 30, 2023

TEClot FIB

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 30, 2023

TECO Factor V Deficient Plasma

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2023

CORNLEY Conditioning Solution

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 15, 2023

RENDER Functional Fibrinogen Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 11, 2023

Rapid Activation Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 11, 2023

Render Heparin Assay (Coagulation Method)

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

TECO TEControl A Plus

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 10, 2023

TECO Calcium Chloride 0.025M

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 3, 2023

TECO Clean Solution

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2023

TECO Rinse Solution

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 3, 2023

TECO IBS Buffer

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 2, 2023

AltaChem Pro Auto Chemistry Analyzer and Accessories

Manufacturer:

GENRUI BIOTECH INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 1, 2023

AIKANG LISS

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 16, 2023

DRAWRAY iStar-D-dimer

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 15, 2023

TECO Dilution Buffer

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 13, 2023

ZEESAN SARS-CoV-2 Test Kit (Real-Time PCR)

Manufacturer:

XIAMEN ZEESAN BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 6, 2023

DIRUI Mg-XB

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

ZHUHAI DL McFCHEK Standards Kit

Manufacturer:

ZHUHAI DL BIOTECH., CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

ADDCARE ADC ELISA 180 Fully Automated ELISA Workstation and Accessories

Manufacturer:

YANTAI ADDCARE BIO-TECH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

YHLO iFlash-Folate

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

LABNOVATION Glycosylated Hemoglobin Test Reagent Kit (HPLC)

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 25, 2023

DRAWRAY Trigger Solution

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

DRAWRAY Wash Buffer

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

Addcare ADC ELISA 200 Fully Automated ELISA Workstation and Accessories

Manufacturer:

YANTAI ADDCARE BIO-TECH LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

LABNOVATION Glycosylated Hemoglobin Test Reagent Kit (HPLC)

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

LABNOVATION Glycosylated Hemoglobin Test Reagent 200 testKit (HPLC)

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 26, 2022

RENDER Hemostatis Analyzer System and Accessories

Manufacturer:

RENDER BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 26, 2022

YHLO iFlash-Ferritin

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

YHLO HSV-2 IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 19, 2022

YHLO iFlash-Mycoplasma pn. IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 19, 2022

YHLO Tumor Marker Multi Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2022

DRAWRAY ISTAR - Anti-TPO

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

YHLO iFlash-Chlamydia pn. IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 14, 2022

Drawray iStar- NT-proBNP

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 14, 2022

YHLO iFlash-Chlamydia pn. IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 9, 2022

Drawray iStar- CK-MB

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2022

YHLO iFlash-Vitamin B12 II

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

DRAWRAY iStar- Anti-TSHR

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

Drawray iStar- Anti-Tg

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2022

YHLO HSV-1 IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 5, 2022

DRAWRAY iStar- PCT

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 5, 2022

ZHUHAI DL-ZD3 Turbidimeter and Accessories

Manufacturer:

ZHUHAI DL BIOTECH., CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 30, 2022

DRAWRAY iStar-Tg

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

YHLO HSV-2 IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2022

YHLO iFlash-Mycoplasma pn. IgG

Manufacturer:

SHENZEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 30, 2022

YHLO HSV-1 IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2022

DRAWRAY iStar-TSH

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

Drawray iStar-FT4

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

DIRUI CS-480 Auto-Chemistry Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

DIRUI Calibrator for Automatic Hematology Analyzer (5 Part)

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 25, 2022

ZEESAN Virus RNA Extraction Kit

Manufacturer:

XIAMEN ZEESAN BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 25, 2022

YHLO iFlash-EB NA IgA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 21, 2022

YHLO iFlash-EB VCA IgA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

YHLO Rubella IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

YHLO iFlash-EB VCA IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

YHLO iFlash-EB EA IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

YHLO iFlash-EB NA IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

YHLO iFlash-EB VCA IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 16, 2022

YHLO CMV IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 14, 2022

YHLO iFlash-IAA

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2022

YHLO iFlash-IA-2A

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2022

DIRUI CS-T240Plus Auto-Chemistry Analyzer and Accessories

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

DIRUI BCC-3960 Automatic Hematology Analyzer and Accessories.

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 7, 2022

DIRUI HCY

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

RAMP Reader System and Accessories

Manufacturer:

RESPONSE BIOMEDICAL CORPORATION.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 3, 2022

YHLO iFlash-ICA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 3, 2022

YHLO iFlash-Laminin

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 2, 2022

DIRUI Clinical Chemical Quality Control Serum Level 1

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2022

YHLO iFlash-AMA-M2

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2022

DIRUI LDL-C

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 27, 2022

YHLO iFlash-GBM IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

YHLO iFlash-ZnT8A

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

Drawray iStar-T4

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2022

YHLO iFlash-HA

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

YHLO iFlash-SMA IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

Drawray iStar-T3

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 21, 2022

Drawray iStar-FT3

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

YHLO iFlash-PIIIPNP

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 20, 2022

YHLO iFlash-Col IV

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2022

YHLO Toxo IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 15, 2022

LABNOVATION HbA1c Calibrator Kit

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 14, 2022

AltaGel Pro Automated Blood Grouping Analyzer

Manufacturer:

AIKANG MEDTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

DIRUI BF - RF Dye

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

DIRUI BF - WFF Dye

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 13, 2022

YHLO iFlash-GADA

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2022

Drawray iStar 500 Chemiluminescence Immunoassay Analyzer and Accessories

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 13, 2022

DIRUI BF - WNF Dye

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 10, 2022

AIKANG ABO/Rh and Reverse Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 10, 2022

LABNOVATION HbA1c Control Kit

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 6, 2022

AIKANG ABO/RhD and Reverse Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 3, 2022

DIRUI BF - RD Diluent

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2022

YHLO iFlash-MPO IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

YHLO iFlash-PR3 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

AIKANG ABO/RHD Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 28, 2022

LABNOVATION LD-560 Fully Automated HbA1c Analyzer and Accessories

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 28, 2022

LABNOVATION Glycosylated Hemoglobin Test Reagent Kit (HPLC)

Manufacturer:

LABNOVATION TECHNOLOGIES, INC.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 27, 2022

DIRUI BF – SLS – II Lyse

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 22, 2022

AIKANG ABO/RH Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 21, 2022

DIRUI Fluorescent Control Level 3

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2022

AIKANG Cell Reservation Solution

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 21, 2022

DIRUI BF -5D-I Diluent

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2022

AIKANG Neutral Card

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 16, 2022

YHLO iFlash RF IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 15, 2022

DIRUI Control for Body Liquid Level 1

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 15, 2022

YHLO iFlash RF

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2022

YHLO I- UNICELL Incubator

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2022

LITUO PAP Stain Kit

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 12, 2022

YHLO iFlash RA33 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2022

AltaGel Star Automated Blood Grouping Analyzer

Manufacturer:

AIKANG MEDTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 8, 2022

YHLO iFlash RF IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 7, 2022

LITUO Cleaning Solution II

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 7, 2022

LITUO Cleaning Solution I

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 6, 2022

YHLO iFlash-PTH

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

YHLO iFlash-β2-Glycoprotein I IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 5, 2022

LITUO Cleaning Solution B

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 5, 2022

LITUO Cleaning Solution A

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Sep 1, 2022

ZEESAN Virus RNA Collection Kit

Manufacturer:

XIAMEN ZEESAN BIOTECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 31, 2022

YHLO iFlash-Anti-β2-Glycoprotein I

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

AIKANG COOMBS CARD

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2022

YHLO iFlash BNP

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2022

LITUO PAP Stain Kit

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 26, 2022

YHLO iFlash-β2-Glycoprotein I IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2022

LITUO HE Stain Kit

Manufacturer:

HUNAN LITUO BIOTECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Aug 25, 2022

AIKANG ANTIBODY DILUENT

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 25, 2022

YHLO iFlash SM IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

YHLO iFlash Jo-1 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 23, 2022

YHLO iFlash - Anti HBc

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 18, 2022

YHLO iFlash Toxo IgG (CLIA)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

YHLO iFlash-Adiponectin

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

AIKANG ABO CARD

Manufacturer:

AIKANG DIAGNOSTICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 16, 2022

YHLO iFlash-Insulin

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

YHLO iFlash-Cortisol

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 15, 2022

YHLO iFlash Troponin-I

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

YHLO iFlash-CK-MB

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

YHLO iFlash-ACTH

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

YHLO iFlash RNP-70 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 12, 2022

YHLO iFlash SS-B IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

YHLO iFlash-β2-Glycoprotein I IgA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 11, 2022

YHLO iFlash Toxo IgM (CLIA)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 3, 2022

YHLO iFlash-Rubella IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 1, 2022

YHLO iFlash CMV IgG (CLIA)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 29, 2022

YHLO iFlash HIV Combo

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 29, 2022

RAMP Cardiac Controls Level 2

Manufacturer:

RESPONSE BIOMEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

YHLO iFlash Scl-70 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

RAMP® Cardiac Controls Level 1

Manufacturer:

RESPONSE BIOMEDICAL CORP

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 26, 2022

YHLO iFlash-Rubella IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 25, 2022

YHLO iFlash – Anti HCV

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2022

YHLO iFlash Anti HBs

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2022

YHLO iFlash Anti HBe Antibody to Hepatitis B e Antigen

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jul 13, 2022

YHLO iFlash-Cardiolipin IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2022

YHLO iFlash-Cardiolipin IgA

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 12, 2022

YHLO iFlash ANA

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2022

YHLO iFlash-Cardiolipin IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2022

DIRUI Fluorescent Calibrator

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 9, 2022

dBEST One Step HCG Card Test

Manufacturer:

AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 7, 2022

YHLO iFlash dsDNA IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

YHLO Rubella IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

YHLO iFlash-Anti-Cardiolipin

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2022

YHLO iFlash Anti TSHR

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2022

YHLO iFlash-PCT (Procalcitonin)

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2022

YHLO iFlash HBeAg Hepatitis B e Antigen

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 9, 2022

YHLO iFlash-NSE

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2022

YHLO iFlash Anti TP (Antibody To Treponema Pallidum) CLIA

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2022

YHLO iFlash-DIGIT 21-1

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2022

YHLO iFlash – PG I (Pepsinogen I)

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 4, 2022

YHLO UNICELL D-DIMER

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 3, 2022

LEPU Nucleic Acid Extraction or Purification Kit

Manufacturer:

BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 3, 2022

YHLO iFlash HBsAg Hepatitis B Surface Antigen

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Jun 1, 2022

YHLO iFlash-25-OH Vitamin D

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 30, 2022

YHLO iFlash CEA

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2022

YHLO iFlash Free PSA (CLIA)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 25, 2022

YHLO iFlash CA 19-9

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2022

YHLO Toxo IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 16, 2022

YHLO iFlash CA 125

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2022

YHLO CMV IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2022

YHLO iFlash CA 15-3 (Cancer Antigen 15-3)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 12, 2022

YHLO iFlash-Anti-TPO

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 12, 2022

dBEST One Step Rapid Test Occult Blood Strip Test

Manufacturer:

AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 10, 2022

DIRUI Fluorescent Control Level 2

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2022

DIRUI Fluorescent Control Level 1

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 9, 2022

YHLO iFlash CMV IgM (CLIA)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2022

YHLO iFlash-HSV-2 IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 29, 2022

dBEST One Step Rapid HCG Strip Test

Manufacturer:

AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 28, 2022

YHLO iFlash FT4

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2022

YHLO iFlash FT3

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2022

YHLO iFlash-Anti-Tg (Antibody to Thyroglobulin)

Manufacturer:

SHENZHEN YHLO BIOTECH, CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2022

YHLO iFlash HSV-1 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2022

YHLO iFlash 1800A Chemiluminescence Immunoassay Analyzer and Accessories

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2022

YHLO iFlash-HSV-2 IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2022

YHLO iFlash-HSV-1 IgM

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 25, 2022

YHLO iFlash T4

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

YHLO iFlash TG Thyroglobulin

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 13, 2022

YHLO iFlash T3

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

SLAN®-96S Real-Time PCR System

Manufacturer:

SHANGHAI HONGSHI MEDICAL TECHNOLOGY CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Apr 11, 2022

YHLO iFLASH TSH

Manufacturer:

SHENZHEN YHLO BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 11, 2022

dBEST One Step Occult Blood Card Test

Manufacturer:

AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 8, 2022

RAMP Procalcitonin Controls Level 1

Manufacturer:

RESPONSE BIOMEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2022

RAMP Procalcitonin Controls Level 2

Manufacturer:

RESPONSE BIOMEDICAL CORPORATION.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 5, 2022

YHLO iFlash-2019-nCoV NAb

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 1, 2022

YHLO UNICELL-2019-nCoV NAb

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2022

YHLO GLINE-2019-nCoV Ag

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2022

ZHUHAI DL-96 NE IST CARD

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 23, 2022

YHLO iFlash-free βhCG

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 15, 2022

ZHUHAI D2Mini Auto Microbial Identification and Antimicrobial Susceptibility Testing System and Accessories

Manufacturer:

ZHUHAI DL BIOTECH., CO. LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 14, 2022

ZHUHAI Enterobact IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 12, 2022

ZHUHAI Strep IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 11, 2022

ZHUHAI Non-Ferment IST Card

Manufacturer:

ZHUHAI DL BIOTECH., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2022

ZHUHAI Staph IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 10, 2022

DIRUI BF-7200 Automatic Hematology System and Accessories

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 9, 2022

DIRUI APTT (Activated Partial Thromboplastin Time)

Manufacturer:

DIRUI INDUSTRIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 31, 2021

ZHUHAI DL-96 E IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 24, 2021

YHLO AMH Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2021

DIATEK Microplate Reader and Accessories

Manufacturer:

WUXI HIWELL-DIATEK INSTRUMENTS CO., LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 18, 2021

DIATEK Microplate Washer and Accessories

Manufacturer:

WUXI HIWELL-DIATEK INSTRUMENTS CO., LTD.,

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 17, 2021

RUNMEI Saliva Collection Kit (Activated)

Manufacturer:

HUNAN RUNMEI GENE TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Dec 13, 2021

YHLO iFlash 1200-A Chemiluminescence Immunoassay Analyzer and Accessories

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 6, 2021

ZENTECH ELIZEN Neonatal 17 - OHP Screening

Manufacturer:

ZENTECH S.A.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2021

ZENTECH Extraction Buffer

Manufacturer:

ZENTECH S.A

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 26, 2021

YHLO PCT Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 24, 2021

YHLO Wash Buffer

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2021

Cornley Electrolytes Quality Control Level 3

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 22, 2021

YHLO Pre-Trigger Solution

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2021

YHLO Trigger Solution

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Nov 22, 2021

Cornley Blood Gas Quality Control

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2021

CORNLEY Blood Gas Quality Control Middle Level

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 18, 2021

Cornley Electrolytes Quality Control Level 2

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2021

CORNLEY Electrolytes Quality Control Level 1

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2021

YHLO 2019-nCoV NAb Control (CLIA)

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 4, 2021

Cornley Electrolytes Quality Control

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 25, 2021

YHLO iFlash-Inhibin A

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2021

CORNLEY Blood Gas Cal pack Ie

Manufacturer:

MEIZHOU CORNLEY HI-TECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 24, 2021

YHLO 2019-nCoV IgM Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 22, 2021

YHLO iFlash-Cleaning Solution

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Oct 18, 2021

CORNLEY BG 800A Blood Gas & Electrolytes Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 13, 2021

YHLO iFlash-PAPP-A

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 12, 2021

CORNLEY Refill Solution (for Reference Electrode)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 12, 2021

CORNLEY Refill Solution (for ISE Electrode)

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2021

MEIZHOU Cornley Calibration Standard Solution

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

YHLO iFlash DHEA-S

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 25, 2021

GD Vaccum Tube Sterile Lithium Heparin

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2021

CORNLEY BG800 Blood Gas & Electrolytes Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

GD Vaccum Tube Sterile Sodium Heparin

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 21, 2021

YHLO UNICELL-2019-nCOV Ag

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 20, 2021

YHLO 2019-nCoV IgG Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 16, 2021

YHLO iFlash Progesterone

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2021

CORNLEY K-LITE 5 Electrolyte Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

YHLO iFlash Prolactin

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 6, 2021

CORNLEY K-LITE 3 Electrolyte Analyzer and Accessories

Manufacturer:

MEIZHOU CORNLEY HI-TECH , CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 31, 2021

YHLO GLINE-2019-nCoV IgM/IgG

Manufacturer:

SHENZHEN YHLO BIOTECH CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 30, 2021

YHLO UNICELL- 25-OH Vitamin D

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2021

DIRUI BF- Diluent

Manufacturer:

DIRUI INDUSTRIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2021

YHLO iFlash-Unconjugated Estriol

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2021

YHLO iFlash LH

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2021

RUNMEI Virus Nucleic Acid Extraction Kit or Nucleic Acid Detection Kit

Manufacturer:

HUNAN RUNMEI GENE TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jul 29, 2021

YHLO iFlash-Testosterone

Manufacturer:

SHENZEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

YHLO iFlash-SARS-CoV-2 IgM (iFlash-2019-nCoV IgM)

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

YHLO iFlash HCG

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 21, 2021

YHLO iFlash FSH

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 15, 2021

YHLO Immunoassay Multi Control

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 3, 2021

RUNMEI Virus Nucleic Acid Extraction Kit or Nucleic Acid Detection Kit

Manufacturer:

HUNAN RUNMEI GENE TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 29, 2021

RUNMEI Full Automatic Nucleic Acid Extract Instrument and Accessories

Manufacturer:

HUNAN RUNMEI GENE TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 24, 2021

YHLO iFlash AMH

Manufacturer:

SHENZEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2021

YHLO iFlash Inhibin B

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2021

CARETIUM XC-A30 Automated Erythrocyte Sedimentation Rate Analyzer and Accessories

Manufacturer:

CARETIUM MEDICAL INSTRUMENTS CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2021

GD Micro Tube EDTA. K3

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

GD Vaccum Tube Sterile SST (W/Gel)

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 6, 2021

GD Micro Tube Plain - 0.5 mL PP

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 5, 2021

GD Vaccum Tube Sterile Glucose

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

GD Vaccum Tube Sterile Clot Activator PET

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

GD Vacuum Tube Sterile Plain

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2021

GD Vacuum Tube Sterile 3,2% Sodium Citrate PET

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

GD Vacuum Tube Sterile EDTA K-3

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

YHLO iFlash-SARS-CoV-2 IgG (iFlash-2019-nCoV IgG)

Manufacturer:

SHENZHEN YHLO BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

GD Vacuum Tube Sterile ESR Tube 3.8% Sodium Citrate 1.28 mL Glass

Manufacturer:

ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 26, 2021

RUNMEI Single – Use Samplers Inactivated

Manufacturer:

HUNAN RUNMEI GENE TECHNOLOGY CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 16, 2021

YHLO UNICELL -cTnI/CK-MB/Myo

Manufacturer:

SHENZHEN YHLO BIOTECH CO,,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 18, 2021

ZHUHAI DL-96 E Auxiliary Reagent

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 9, 2020

ZHUHAI DL-96 STAPH Auxiliary Reagent

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 29, 2020

ZHUHAI DL-96 E IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2020

ZHUHAI DL-96 FUNGUS AUXILIARY REAGENT

Manufacturer:

ZHUHAI DL BIOTECH CO, LTD.,

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2020

ZHUHAI DL-96 NE Auxiliary Reagent

Manufacturer:

ZHUHAI DL BIOTECH CO.,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 21, 2020

ZHUHAI DL-96 STREP Auxiliary Reagent

Manufacturer:

ZHUHAI DL BIOTECH CO,LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2020

ZHUHAI DL-96 NE IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 6, 2020

ZHUHAI DL-96 Fungus IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 27, 2020

ZHUHAI DL - 96 STAPH IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 25, 2020

ZHUHAI DL - 96 STREP IST Card

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 20, 2020

DIRUI BF-CRP REAGENT KIT

Manufacturer:

DIRUI INDUSTRIAL., CO, LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 16, 2020

DBESTOne Step Rapid Test Neonatal TSH Whole Blood

Manufacturer:

AMERITECH DIAGNOSTIC REAGENT (JIAXING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 2, 2020

ZHUHAI DL-96 II Auto Microbial Identification and Antimicrobial Susceptiability Testing System with Accessories

Manufacturer:

ZHUHAI DL BIOTECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 1, 2020

dBest One Step Rapid Test LH Ovulation Card Test

Manufacturer:

AMERITEK, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2019

dBEST One Step Rapid Test LH Ovulation Strip Test

Manufacturer:

AMERITEK, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2019

dBEST One Step Rapid Test Occult Blood Strip Test

Manufacturer:

AMERITEK, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2019

dBEST One Step Rapid HCG Strip Test

Manufacturer:

AMERITEK, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 19, 2019

dBEST One Step Occult Blood Card Test

Manufacturer:

AMERITEK, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 1, 2019

dBEST One Step HCG Card Test

Manufacturer:

AMERITEK, INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 28, 2019

TECO COATRON M1 Coagulation Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENT PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 15, 2018

TECO TEChrom AT (anti-Xa) Liquid

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2018

TECO Coatron M4 Manual 4-Channel Coagulation Analyzer and Accessories

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 23, 2018

TEClot LA Screen

Manufacturer:

TECO MEDICAL INSTRUMENTS PRODUCTION + TRADING GMBH.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 4, 2018

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

Last updated: December 2025