Pure Global

FOSUN Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit - Indonesia BPOM Medical Device Registration

FOSUN Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220008. The device is manufactured by FOSUN DIAGNOSTICS (SHANGHAI) CO., LTD from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ENVIRO MEDITECH PRIMARY.

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
FOSUN Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
Analysis ID: AKL 20303220008

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. ENVIRO MEDITECH PRIMARY

AR Address

Jl.Tanah Abang II No.67

Registration Date

Feb 09, 2023

Expiry Date

Aug 10, 2026

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