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HEALGEN HBsAb Rapid Test Strip - Indonesia BPOM Medical Device Registration

HEALGEN HBsAb Rapid Test Strip is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305020237. 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.

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BPOM Registered
Risk Class Kelas Resiko : D
HEALGEN HBsAb Rapid Test Strip
Analysis ID: AKL 30305020237

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

China

Authorized Representative

PT. BINTANG MONO INDONESIA

AR Address

Perum Mahkota Simprug Blok A13 No. 9

Registration Date

Jan 26, 2020

Expiry Date

Jul 09, 2024

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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DJ Fang

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