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GENEFIRST Covid-19 Detection Kit - Indonesia BPOM Medical Device Registration

GENEFIRST Covid-19 Detection Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303125999. The device is manufactured by GENEFIRST LIMITED from United Kingdom, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SETIA GUNA MEDIKA.

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 : B
GENEFIRST Covid-19 Detection Kit
Analysis ID: AKL 20303125999

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

GENEFIRST LIMITED

Country of Origin

United Kingdom

Authorized Representative

PT. SETIA GUNA MEDIKA

AR Address

KOMPLEK TAMAN KEBUN JERUK BLOK AA IV NO. 39-40, KEBUN JERUK, JAKARTA BARAT

Registration Date

Oct 08, 2022

Expiry Date

Nov 19, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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