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GeneProof Hepatitis B Virus (HBV) PCR Kit - Indonesia BPOM Medical Device Registration

GeneProof Hepatitis B Virus (HBV) PCR Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220009. The device is manufactured by GENEPROOF A.S. from Czech Republic, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. BIOSAINS MEDIKA 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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Risk Class Kelas Resiko : D
GeneProof Hepatitis B Virus (HBV) PCR Kit
Analysis ID: AKL 30305220009

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Manufacturer

GENEPROOF A.S.

Country of Origin

Czech Republic

Authorized Representative

PT. BIOSAINS MEDIKA INDONESIA

AR Address

PERMATA DEPOK MUTIARA BLOK.A NO.7 RT.001/RW.007 KELURAHAN PONDOK JAYA KECAMATAN CIPAYUNG KOTA DEPOK

Registration Date

Jan 14, 2022

Expiry Date

Mar 26, 2026

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

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DJ Fang

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