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HEALGEN COC Test Casssette - Indonesia BPOM Medical Device Registration

HEALGEN COC Test Casssette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20103612881. The device is manufactured by ZHEJIANG ORIENT GENE BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BINTANG MONO INDONESIA.

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.

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BPOM Registered
Risk Class Kelas Resiko : B
HEALGEN COC Test Casssette
Analysis ID: AKL 20103612881

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. BINTANG MONO INDONESIA

AR Address

TAMAN TEKNO BSD SEKTOR XI BLOK J 3 NOMOR 25

Registration Date

Jun 28, 2024

Expiry Date

Nov 23, 2027

Product Type

Clinical Toxicology Test System

Cocaine and cocaine metabolite test system(card)

Invitro Diagnostics

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DJ Fang

DJ Fang

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