Pure Global

ORIENT GENE HBsAb Test Cassette - Indonesia BPOM Medical Device Registration

ORIENT GENE HBsAb Test Cassette is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305915282. The device is manufactured by ZHEJIANG ORIENT GENE BIOTECH CO, LTD. from China, and is classified as Risk Class Kelas Resiko : D. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : D
ORIENT GENE HBsAb Test Cassette
Analysis ID: AKL 30305915282

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. BINTANG MONO INDONESIA

AR Address

TAMAN TEKNO BSD SEKTOR XI BLOK J 3 NOMOR 25

Registration Date

Apr 22, 2024

Expiry Date

Nov 22, 2027

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing