Pure Global

Onsite HAV IgG/IgM Rapid Test - Indonesia BPOM Medical Device Registration

Onsite HAV IgG/IgM Rapid Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303321004. The device is manufactured by CTK BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. RAJAERBA INDOCHEM.

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
Onsite HAV IgG/IgM Rapid Test
Analysis ID: AKL 20303321004

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

CTK BIOTECH, INC.

Country of Origin

United States

Authorized Representative

PT. RAJAERBA INDOCHEM

AR Address

GEDUNG PEMBINA GRAHA JL. DI. PANJAITAN NO.45 RAWA BUNGA

Registration Date

Mar 01, 2023

Expiry Date

Aug 25, 2026

Product Type

Serological Reagents

Hepatitis A virus (HAV) serological assays.

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing