Pure Global

ACRO hCG Pregnancy Rapid Test Cassette (Urine) - Indonesia BPOM Medical Device Registration

ACRO hCG Pregnancy Rapid Test Cassette (Urine) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101222383. The device is manufactured by ACRO BIOTECH, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is Rafa Topaz Main.

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
ACRO hCG Pregnancy Rapid Test Cassette (Urine)
Analysis ID: AKL 20101222383

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

ACRO BIOTECH, INC.

Country of Origin

United States

Authorized Representative

Rafa Topaz Main

AR Address

Taman Buaran Indah I Blok U No. 242 Jl. Radin Inten II, Klender, Jakarta Timur

Registration Date

Dec 31, 2022

Expiry Date

Aug 19, 2026

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing