Pure Global

BIOCARE Dengue IgG/IgM & Dengue NS1 Antigen Rapid Test Device - Indonesia BPOM Medical Device Registration

BIOCARE Dengue IgG/IgM & Dengue NS1 Antigen Rapid Test Device is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220787. The device is manufactured by ASSURE TECH (HANGZHOU) CO., LTD. from China, and is classified as Risk Class Kelas Resiko : C. 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 : C
BIOCARE Dengue IgG/IgM & Dengue NS1 Antigen Rapid Test Device
Analysis ID: AKL 20303220787

Risk Classification

Kelas Resiko : C

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

Nov 14, 2022

Expiry Date

Sep 13, 2025

Product Type

Serological Reagents

Dengue virus serological reagents

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing