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PT. CEKINDO BUSINESS INTERNATIONAL

Authorized Representative in Indonesia

Gedung Axa Tower Lantai 36, Jalan Profesor Doktor Satrio Kaveling 18
215 Products Represented
53 Manufacturers
Total Products
215
Manufacturers
53
Product Classes
3
Risk Classes
4
Risk Classification Breakdown
Distribution of represented products across risk classes
Kelas Resiko : A
13 products
6.0%
Kelas Resiko : B
113 products
52.6%
Kelas Resiko : C
79 products
36.7%
Kelas Resiko : D
10 products
4.7%
Manufacturer Portfolio
Products organized by manufacturer
All Represented Products (215)
Complete portfolio registered with BPOM

BRIVIEW Imaging Processor System (Including Light Source)

Manufacturer:

SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

BRIVIEW Disposable Electronic Flexible Choledochoscope

Manufacturer:

SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 10, 2025

RANDOX Total Antioxidant Status (TAS)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 5, 2025

RANDOX Glutathione Peroxide (RANSEL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

RANDOX Ransel Control

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

RANDOX Glutathione Peroxide (RANSEL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 3, 2025

RANDOX Ransel Calibrator (RANSEL CAL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 24, 2025

RANDOX Serology III Positive Control (Serology III Control +)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 23, 2025

RANDOX Serology II Positive Control (Serology II Control +)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2025

RANDOX Serology I Positive Control (Serology I Control +)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 22, 2025

RANDOX Total Antioxidant Status (TAS CONTROL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

REALCON Color 38 Soft Contact Lens

Manufacturer:

JILIN REALCON OPTICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 20, 2025

IMAGEMATE Single-use High-pressure Angiographic Syringes and Accessories

Manufacturer:

SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 20, 2025

RANDOX Serology Negative Control (Serology Control -)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 20, 2025

RANDOX sLDL Calibrator (sLDL CAL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

RANDOX sLDL Control Level 2 (sLDL CONTROL 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 17, 2025

MIIEMO Soft Contact Lens

Manufacturer:

SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 15, 2025

HEALTHTREE Hearing Aid

Manufacturer:

GUANGDONG HEALTHTREE MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 14, 2025

MICROLIFE Nebulizer

Manufacturer:

GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2025

BULL

Manufacturer:

DEKA M.E.L.A S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 2, 2025

RANDOX sLDL Control Level 3 (sLDL CONTROL 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 27, 2024

RANDOX sLDL Control Level 1 (sLDL CONTROL 1)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 23, 2024

MICROLIFE Blood Pressure Monitor

Manufacturer:

ONBO ELECTRONICS (SHENZEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 17, 2024

RANDOX Glucose-6-Phosphate Dehydrogenase (G-6-PDH)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 9, 2024

RANDOX G6P-DH Deficient Control (G-6-PDH Control D)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

MICROLIFE Blood Pressure Monitor with AFIB detection

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 6, 2024

RANDOX G-6-PDH Normal Control (G-6-PDH Control N)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 2, 2024

MICROLIFE Blood Pressure Monitor with AFIB detection

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 29, 2024

STREAMER™ Intracranial Balloon Dilation Catheter

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 13, 2024

FLAGER™ Neurovascular Guidewire

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

UTILITY Occlusion Balloon Catheter

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Nov 11, 2024

STERIS Hinge-Free ™ Instrument Lubricant

Manufacturer:

STERIS CORPORATION ST. LOUIS OPERATIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 10, 2024

Imagemate Single-use High-pressure Angiographic Syringes and Accessories

Manufacturer:

SUZHOU HENGRUI HONGYUAN MEDICAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 1, 2024

MICROLIFE Digital Thermometer

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 31, 2024

MOTUS PRO

Manufacturer:

DEKA M.E.L.A S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 21, 2024

ADDCARE Fully Automated Blood Grouping System

Manufacturer:

YANTAI ADDCARE BIO-TECH CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

LinX Continuous Glucose Monitoring System

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 18, 2024

CHAORUM Healing Abutment

Manufacturer:

MEDIMECCA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 24, 2024

MICROLIFE Non Contact Forehead Thermometer

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 24, 2024

MICROLIFE Non Contact Forehead Thermometer

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 23, 2024

MICROLIFE Blood Pressure Monitor

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 17, 2024

MICROLIFE Blood Pressure Monitor with AFIB detection

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 13, 2024

SMARTXIDE Tetra Pro

Manufacturer:

DEKA M.E.L.A S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 12, 2024

MICROLIFE Digital Thermometer

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

MICROLIFE WatchBP Office ABI Blood Pressure Monitor

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 11, 2024

MICROLIFE Compressor Nebulizer

Manufacturer:

GLOBALCARE MEDICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 9, 2024

MICROLIFE Blood Pressure Monitor

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Sep 7, 2024

Target Medical Disposable Hemodialysis Catheter Kit-Double Lumen

Manufacturer:

BEIJING TARGET MEDICAL TECHNOLOGIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Sep 6, 2024

Target Medical Disposable Hemodialysis Catheter Kit-Triple Lumen

Manufacturer:

BEIJING TARGET MEDICAL TECHNOLOGIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 30, 2024

EXACTIVE Glucose Control Solution

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 28, 2024

VESSCIDE Cutting Balloon Dilatation Catheter

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2024

MADSEN Zodiac SA Diagnostic Clinical

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 14, 2024

PERDENSER Embolic Coil System

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 8, 2024

MADSEN Zodiac PC Diagnostic Clinical

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2024

MADSEN Zodiac SA Quick Check

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 7, 2024

VESSELIN Drug Coated Coronary Balloon Catheter

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 5, 2024

GUREATER CoCr Sirolimus-eluting Coronary Stent System

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 5, 2024

CHISON Ultrasound Diagnostic System

Manufacturer:

CHISON MEDICAL TECHNOLOGIES CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

Madsen Zodiac PC Quick Check

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 4, 2024

NUVA Flow Diverter

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 2, 2024

RANDOX Coagulation Control - Level 1 (COAG CONTROL 1)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 29, 2024

MICROLIFE Flexible Tip Digital Thermometer

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 11, 2024

PROLYSTICA ™ 2X Concentrate Neutral Detergent

Manufacturer:

STERIS CORPORATION ST. LOUIS OPERATIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 5, 2024

DEROMPER Coil Detachment Controller

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 2, 2024

PROLYSTICA™ 2X Concentrate Alkaline Detergent

Manufacturer:

STERIS CORPORATION ST. LOUIS OPERATIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

MICROLIFE Blood Pressure Monitor

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 24, 2024

RANDOX Haematology Control Level 1,2,3 (HAEM CNTL – LEVEL 1,2,3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 19, 2024

EXACTIVE PRO Blood Glucose Test Strips

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 19, 2024

PROLYSTICA™ 2x Concentrate Enzymatic Presoak and Cleaner

Manufacturer:

STERIS CORPORATION ST. LOUIS OPERATIONS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2024

Excilite μ

Manufacturer:

DEKA M.E.L.A. S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 9, 2024

ECO Microwave Therapeutic System

Manufacturer:

ECO MEDICAL TECHNOLOGY (NANJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 6, 2024

CHISON Ultrasound Diagnostic Systems

Manufacturer:

CHISON MEDICAL TECHNOLOGIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

CHISON Ultrasound Diagnostic Systems

Manufacturer:

CHISON MEDICAL TECHNOLOGIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 20, 2024

MADSEN Astera

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 8, 2024

CHISON Ultrasound Diagnostic System

Manufacturer:

CHISON MEDICAL TECHNOLOGIES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 7, 2024

MADSEN A450

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 24, 2024

BOSCH Vivalytic One

Manufacturer:

LRE MEDICAL GMBH

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 23, 2024

SCARCLINIC ™ Clear

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 6, 2024

RANDOX Direct LDL/HDL Cholesterol Calibrator (D LDL/HDL CAL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 27, 2024

RANDOX Lipid Control – Level 3 (LPD CONTROL 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 26, 2024

RANDOX Tri-Level Cardiac Control (CRD Control 1,2,3)

Manufacturer:

RANDOX LABORATORIES LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

RANDOX ACUSERA Human Assayed Multi-Sera/Assayed Chemistry Premium Plus - Level 3 (HUM ASY CONTROL 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 25, 2024

EQUIL™ Ambulatory Insulin Infusion Pumps

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 22, 2024

SCARCLINIC ™ Gel

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 22, 2024

BONDENT Dental Unit

Manufacturer:

SICHUAN BOMESIN DENTAL EQUIPMENT CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 22, 2024

EXACTIVE PRO Ketone Test Strip

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 20, 2024

EXACTIVE PRO Uric Acid Test Strip

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 19, 2024

EXACTIVE PRO Glucose, Ketone and Uric Acid Meter

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 18, 2024

RANDOX Immunoassay Premium Plus Tri-Level (IA Premium Plus Tri-Level)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2024

RANDOX Blood Gas Control – Level 3 (BG CONTROL 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2024

RANDOX Human Assayed Multi-Sera/Assayed Chemistry Premium Plus - Level 2 (HUM ASY CONTROL 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2024

RANDOX Blood Gas Control – Level 1 (BG CONTROL 1)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2024

RANDOX Assayed Urine Control – Level 3 (URN ASY CONTROL 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 15, 2024

RANDOX Ammonia Ethanol Control - Level 3 (NH3/EtOH Control 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2024

RANDOX AMMONIA ETHANOL CONTROL - LEVEL 2 (NH3/EtOH Control 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 14, 2024

EQUIL ™ Insulin Infusion Pump Reservoirs

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 13, 2024

10THERA

Manufacturer:

ASTERASYS CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 6, 2024

RANDOX Ammonia Ethanol Control - Level 1 (NH3/EtOH Control 1)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Mar 5, 2024

MicroTech Medical Blood Lancets

Manufacturer:

PROMISEMED HANGZHOU MEDITECH CO., LTD

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Mar 5, 2024

STASPIR™ Aspiration Pump

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 17, 2024

EXACTIVE Blood Glucose Test Strips

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 7, 2024

Leechor Thrombus Aspiration Catheter

Manufacturer:

BEIJING TAIJIEWEIYE TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 11, 2024

CHAORUM Angled Abutment

Manufacturer:

MEDIMECCA CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 4, 2024

KERNA™ Surgical Table

Manufacturer:

STERIS SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 3, 2024

AiDEX ™ Continuous Glucose Monitoring System

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 3, 2024

CMAX X-Ray Surgical Table

Manufacturer:

STERIS SAS

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 2, 2024

AiDEX ™ Lite Continuous Glucose Monitoring System

Manufacturer:

MICROTECH MEDICAL (HANGZHOU) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 30, 2023

RANDOX Tumour Marker Control - Level 2 (TMR Control 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 7, 2023

SAFECATH™ Disposable Single-lumen Central Venous Catheter Kits

Manufacturer:

BEIJING TARGET MEDICAL TECHNOLOGIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 30, 2023

SAFECATH™ Disposable Double-lumen Central Venous Catheter Kits

Manufacturer:

BEIJING TARGET MEDICAL TECHNOLOGIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

SAFECATH™ Disposable Triple-lumen Central Venous Catheter Kits

Manufacturer:

BEIJING TARGET MEDICAL TECHNOLOGIES INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 28, 2023

RANDOX Tumour Marker Control – Level 3 (TMR Control 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 23, 2023

RANDOX Liquid Assayed Specific Protein Control – Level 2 (SP Control 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 23, 2023

YUWELL ANYTIME Continuous Glucose Monitoring System

Manufacturer:

ZHEJIANG POCTECH CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Nov 22, 2023

RANDOX hsCRP CONTROL 2

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

RANDOX URNAL Control 1

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 17, 2023

RANDOX URN ASY CONTROL 2

Manufacturer:

RANDOX LABORATORIES LIMITED.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

RANDOX Urinalysis Control – Level 2 (URNAL CONTROL 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 16, 2023

RANDOX High Sensitivity CRP Control - Level 1 (hsCRP CONTROL 1)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

RANDOX LIQUID URINE CONTROL – LEVEL 2 (LIQ URN CONTROL 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

RANDOX Liquid Assayed Specific Protein Control – Level 1 (SP Control 1)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

RANDOX Liquid CRP Control – Level 2 (CRP Control 2)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 14, 2023

MICROLIFE Non Contact Forehead Thermometer

Manufacturer:

ONBO ELECTRONIC (SHENZHEN) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 13, 2023

RANDOX CK-MB Calibrator (CK-MB CAL)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 8, 2023

RANDOX HbA1C Control

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

RANDOX Calibration Serum - Level 3 (CAL 3)

Manufacturer:

RANDOX LABORATORIES LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Nov 6, 2023

AURICAL AUD

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 30, 2023

ALLIGATOR™ Powered Endoscopic Staplers

Manufacturer:

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 27, 2023

BV Rapid Blue ™ Bacterial Vaginosis Detection Kit

Manufacturer:

MINGWOOD BIOTECHNOLOGY BEIJING, LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Oct 15, 2023

OCI Hollow Fiber Dialyzer

Manufacturer:

CHENGDU OCI MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Oct 11, 2023

H-STENT™ Coronary Stent Delivery System

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Sep 7, 2023

PARTNER™ Sirolimus-eluting Coronary Stent System

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

Class:

Kelas : 3

Risk Class:
Kelas Resiko : D
Registration Date:

Aug 27, 2023

TADPOLE ™ Coronary Dilatation Catheter

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2023

NC TADPOLE™ Coronary Dilation Catheter

Manufacturer:

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 21, 2023

DOPHI™ Radiofrequency Ablation System

Manufacturer:

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Aug 9, 2023

INFLACURE™ Gas Insufflator

Manufacturer:

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Aug 3, 2023

WALKMAN Metal Locking Bone Screws and Plate System III

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 9, 2023

MINT ™ FINE PLUS

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 7, 2023

WALKMAN Metal Locking Bone Screws and Plate System II

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jul 6, 2023

LEPU MEDICAL Electrocardiograph

Manufacturer:

SHENZHEN CAREWELL ELECTRONICS CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jul 6, 2023

SONICURE™ Ultrasonic Scalpel System

Manufacturer:

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 27, 2023

DOPHI™ Electroporation System

Manufacturer:

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 25, 2023

KEYU FOB multi-level indefinite value controls

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 23, 2023

VARICURE™ Ultrasonic Surgical & Electrosurgical System

Manufacturer:

SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 23, 2023

KEYU Urine Reagent Strips

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 21, 2023

FOREAL Disposable Latex Exam Gloves

Manufacturer:

TOP GLOVE SDN. BHD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 19, 2023

KEYU Dry Chemistry Urine analysis Control

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 17, 2023

KEYU Urine Sediment Analyzer Quality Control

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

WALKMAN Metal Pin

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2023

KEYU Feces Formed Element Control

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

KEYU Calprotectin Test Kit (Colloidal gold method)

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 13, 2023

WALKMAN Cannulated Screw System

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 13, 2023

KEYU Concentrated Cleaning Solution

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 11, 2023

KEYU Sample Diluent

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 11, 2023

KEYU Urine Sample Collection Tube

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jun 11, 2023

KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 11, 2023

WALKMAN Patellar Rings

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jun 7, 2023

KEYU Feces Analyzer

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jun 1, 2023

WALKMAN Metal Bone Plates (Angular)

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 29, 2023

KEYU Feces Analyzer

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 29, 2023

KEYU Dry Chemistry Urine Analyzer

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

KEYU Automatic Urine Analysis System

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

KEYU Urine Sediment Analyzer

Manufacturer:

ZHUHAI KEYU BIOLOGICAL ENGINEERING CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

May 23, 2023

WALKMAN Metal Locking Bone Screws and Plate System

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 22, 2023

WALKMAN Metal Intramedullary Interlocking Nailing Systems

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 22, 2023

LIKE ™ Fix Mini

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

May 20, 2023

B. & B. DENTAL Surgical Kit for Pterygoid Implants

Manufacturer:

B. & B. DENTAL S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

May 10, 2023

B. & B. DENTAL DURAVIT Crestal Sinus Lift Kit

Manufacturer:

B. & B. DENTAL S.R.L.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Apr 18, 2023

B&B DENTAL Drills

Manufacturer:

B. & B. DENTAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Apr 6, 2023

LIKE™ Petit

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 29, 2023

NC THONIC ™ Non Compliant PTCA Balloon Dilatation Catheter

Manufacturer:

SINO MEDICAL SCIENCES TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 27, 2023

TYTRAK ™ PTCA Balloon Catheter

Manufacturer:

SINO MEDICAL SCIENCES TECHNOLOGY INC.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 26, 2023

OCI Hemodialysis Blood Tubing Sets

Manufacturer:

CHENGDU OCI MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 23, 2023

OCI Hollow Fiber Membrane Hemodialyzer

Manufacturer:

CHENGDU OCI MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

OCI Arteriovenous Fistula Needle Sets

Manufacturer:

CHENGDU OCI MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

MINT™ Easy

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 22, 2023

MINT™ Tip

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2023

AS™ Fix

Manufacturer:

HANSBIOMED CORP.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2023

T-BARRIER Titanium Membrane

Manufacturer:

B. & B. DENTAL S.R.L.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 15, 2023

WALKMAN Metal Bone Plates

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

WALKMAN Intramedullary Nailing Systems

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

OCI Low-Flux Polyethersulfone Hollow Fiber Hemodialyzer

Manufacturer:

CHENGDU OCI MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

OCI High-Flux Polyethersulfone Hollow Fiber Hemodialyzer

Manufacturer:

CHENGDU OCI MEDICAL DEVICES CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

WALKMAN Metal Pin

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

WALKMAN Metal Bone Screws

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

WALKMAN Ortho-bridges System

Manufacturer:

TIANJIN WALKMAN BIOMATERIAL CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Mar 6, 2023

ELECTRO LUBE

Manufacturer:

PURPLE SURGICAL MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2023

SANSIN Hollow Fiber Haemodialysis Dialysers for Single Use

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2023

SANSIN Hollow Fiber Haemodialysis Dialysers for Single Use

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Feb 27, 2023

LEPU MEDICAL Lipid Profile Test Strip

Manufacturer:

BEIJING LEPU MEDICAL TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 9, 2023

AURICAL HIT

Manufacturer:

VTECH (DONGGUAN) COMMUNICATIONS LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

JUSHA LCD Monitor - JUSHA-M53

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

JUSHA LCD MONITOR - C450G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 2, 2023

AURICAL FREEFIT

Manufacturer:

NATUS MANUFACTURING LIMITED

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Feb 1, 2023

Otometrics Otoscan

Manufacturer:

SYNCRON EMS

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Feb 1, 2023

SANSIN Hollow Fiber Haemodialysis Dialysers for Single Use

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 31, 2023

JUSHA LCD Monitor - E240AG

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2023

JUSHA LCD MONITOR - M350G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2023

JUSHA LCD MONITOR - C350G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2023

JUSHA LCD Monitor - C630G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2023

JUSHA LCD MONITOR - E270AG

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 26, 2023

SANSIN Hemodialysis Powders

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

ECP- PSK Air-bag Type Sequential External Counter-pulsation Device P-ECP/TM

Manufacturer:

CHONGQING PSK-HEALTH SCI-TECH DEVELOPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

SANSIN Sterile Hemodialysis Blood Circuits for Single Use

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

SANSIN A.V. Fistula Needle Sets

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

AURICAL Otocam 300

Manufacturer:

GPV ASIA (THAILAND) CO., LTD.

Class:

Kelas : 1

Risk Class:
Kelas Resiko : A
Registration Date:

Jan 25, 2023

REALCON COLOR 40 soft contact lens

Manufacturer:

JILIN REALCON OPTICAL TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

SANSIN Hemodialysis Powders

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

SANSIN Hollow Fiber Haemodialysis Dialysers for Single Use

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

ECP PSK Air-bag Type Sequential External Counter-pulsation Device P-ECP/TI

Manufacturer:

CHONGQING PSK-HEALTH SCI-TECH DEVELOPMENT CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Jan 25, 2023

JUSHA LCD Monitor - CR240G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 1, 2023

JUSHA LCD MONITOR - M260G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Jan 1, 2023

JUSHA LCD Monitor - C270G

Manufacturer:

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD

Class:

Kelas : 2

Risk Class:
Kelas Resiko : B
Registration Date:

Dec 29, 2022

SANSIN A.V. Fistula Needle Sets

Manufacturer:

JIANGXI SANXIN MEDTEC CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 28, 2022

OPTACT Revision Overnight Wear Orthokeratology Contact Lens

Manufacturer:

VISION TECHNOLOGY CO., LTD.

Class:

Kelas : 2

Risk Class:
Kelas Resiko : C
Registration Date:

Dec 23, 2022

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

Last updated: December 2025