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Genedrive (HCV) - Indonesia BPOM Medical Device Registration

Genedrive (HCV) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20304023693. The device is manufactured by GENEDRIVE DIAGNOSTICS LTD. from United Kingdom, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. SYSMEX 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 : C
Genedrive (HCV)
Analysis ID: AKL 20304023693

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

United Kingdom

Authorized Representative

PT. SYSMEX INDONESIA

AR Address

Cyber 2 Tower, 5th Floor Unit E Jl. HR. Rasuna Said Blok X.5 No.13

Registration Date

Jul 06, 2020

Expiry Date

Oct 17, 2024

Product Type

Immunology Laboratory Equipment and Reagents

RNA Preanalytical Systems.

Invitro Diagnostics

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