Pure Global

BIOSYNEX AMPLIQUICK Sars Cov 2 - Indonesia BPOM Medical Device Registration

BIOSYNEX AMPLIQUICK Sars Cov 2 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303320972. The device is manufactured by BIOSYNEX Ltd. from France, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PACIFIC SAINTIFINDO.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
BIOSYNEX AMPLIQUICK Sars Cov 2
Analysis ID: AKL 20303320972

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

BIOSYNEX Ltd.

Country of Origin

France

Authorized Representative

PT. PACIFIC SAINTIFINDO

AR Address

PASIFIK SAINTIFINDO

Registration Date

Feb 09, 2023

Expiry Date

Feb 06, 2024

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing