PRODIGY Blood Glucose Test Strips - Indonesia BPOM Medical Device Registration

PRODIGY Blood Glucose Test Strips is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101412143. The device is manufactured by OK BIOTECH CO., LTD. from Taiwan (China), and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. MAIN MEDICAL CHAKRA.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : C

PRODIGY Blood Glucose Test Strips

Analysis ID: AKL 20101412143

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

OK BIOTECH CO., LTD.

Country of Origin

Taiwan (China)

Authorized Representative

PT. MAIN MEDICAL CHAKRA

AR Address

FORESTA BUSINESS LOFT 6 No. 10, Jl. Raya Boulevard Utara BSD City, Desa/Kelurahan Lengkong Kulon

Registration Date

Dec 29, 2022

Expiry Date

Nov 04, 2027

Product Type

Clinical Chemistry Test System

Glucose test system (strip & midstream)

Invitro Diagnostics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from OK BIOTECH CO., LTD.

Products from the same manufacturer (1 products)

PRODIGY AUTOCODE Blood Glucose Meter and Accessories

Kelas Resiko : C

Other Products from PT. MAIN MEDICAL CHAKRA

Products with the same authorized representative (10 products)

VivaDiag™ Progesterone Test Kit (FIA)

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Kelas Resiko : B

VivaDiag™ Free Thyroxine Control Solution (FIA)

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Kelas Resiko : B

VivaDiag™ Free Triiodothyronine Control Solution (FIA)

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Kelas Resiko : B

VivaDiag™ Testosterone Test Kit (FIA)

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Kelas Resiko : B

BALIO - CLE-P Cleanser

SHENZHEN DYMIND BIOTECHNOLOGY CO.,LTD

Kelas Resiko : A

CITEST Multi-Drug 6 Drugs Rapid Test Panel (Urine) (MOP300/COC300/AMP1000/MET1000/THC50/BZO300)

CITEST DIAGNOSTICS INC

Kelas Resiko : C

VivaDiag Glycosylated Hemoglobin Control Solution

VIVACHEK BIOTECH (HANGZHOU) CO., LTD

Kelas Resiko : B

CITEST™ Urine Analyzer AUR-200 and Accessories

HANGZHOU ALLTEST BIOTECH CO.,LTD

Kelas Resiko : B

VivaDiag™ POCT Analyzer VIM3000

VIVACHEK BIOTECH (HANGZHOU) CO., LTD., CHINA.

Kelas Resiko : B

CITEST™ Urinalysis Reagent Strips - 10U (Urine) (LEU/NIT/URO/PRO/pH/BLO/SG/KET/BIL/GLU)

HANGZHOU ALLTEST BIOTECH CO.,LTD

Kelas Resiko : C