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ACON SARS-CoV-2 IgG/IgM Rapid Test - Indonesia BPOM Medical Device Registration

ACON SARS-CoV-2 IgG/IgM Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303025451. The device is manufactured by ACON BIOTECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MITRA BAHAGIA CITRA 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
ACON SARS-CoV-2 IgG/IgM Rapid Test
Analysis ID: AKL 20303025451

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MITRA BAHAGIA CITRA MEDIKA

AR Address

Jl. Raya Kalirungkut 27 Blok C-63

Registration Date

Oct 11, 2021

Expiry Date

Jun 09, 2025

Product Type

Serological Reagents

Respiratory viral panel multiplex nucleic acid assay

Invitro Diagnostics

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DJ Fang

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