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BIOCARE HAV IgM Rapid Test Device - Indonesia BPOM Medical Device Registration

BIOCARE HAV IgM Rapid Test Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303320945. The device is manufactured by ASSURE TECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PROSPEROUS BIOCARE.

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
BIOCARE HAV IgM Rapid Test Device
Analysis ID: AKL 20303320945

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. PROSPEROUS BIOCARE

AR Address

Ruko Kranggan Permai Blok RT 17 No. 30 Jatisampurna, Bekasi, Jawa Barat 17433

Registration Date

Jan 25, 2023

Expiry Date

Sep 13, 2025

Product Type

Serological Reagents

Hepatitis A virus (HAV) serological assays.

Invitro Diagnostics

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DJ Fang

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