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Geenius HCV Supplemental Assay - Indonesia BPOM Medical Device Registration

Geenius HCV Supplemental Assay is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305320911. The device is manufactured by BIO-RAD. (STEENVOORDE) from France, and is classified as Risk Class Kelas Resiko : D. The authorized representative in Indonesia is PT. ANDAMAN MEDICAL 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
Geenius HCV Supplemental Assay
Analysis ID: AKL 30305320911

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

Country of Origin

France

Authorized Representative

PT. ANDAMAN MEDICAL INDONESIA

AR Address

Menara Cardig Lantai 1, Jalan Raya Halim Perdanakusuma

Registration Date

Jun 19, 2023

Expiry Date

Sep 01, 2025

Product Type

Immunological Test System

Antinuclear antibody immunological test system.

Invitro Diagnostics

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DJ Fang

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