Pure Global

BIOCARE HEV IgM Rapid Test Device (Serum/Plasma) - Indonesia BPOM Medical Device Registration

BIOCARE HEV IgM Rapid Test Device (Serum/Plasma) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 30305220563. The device is manufactured by ASSURE TECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : D. 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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : D
BIOCARE HEV IgM Rapid Test Device (Serum/Plasma)
Analysis ID: AKL 30305220563

Risk Classification

Kelas Resiko : D

Product Class

Kelas : 3

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

Dec 06, 2022

Expiry Date

Sep 13, 2025

Product Type

Immunological Test System

Antimitochondrial antibody immunological test system.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing