Pure Global

dBEST One Step Rapid HCG Strip Test - Indonesia BPOM Medical Device Registration

dBEST One Step Rapid HCG Strip Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101501618. The device is manufactured by AMERITEK, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. FAITHFUL MEDICAL GRACE.

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
dBEST One Step Rapid HCG Strip Test
Analysis ID: AKL 20101501618

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

AMERITEK, INC.

Country of Origin

United States

Authorized Representative

PT. FAITHFUL MEDICAL GRACE

AR Address

Mitra Sunter Boulevard Blok B No.39 Jl. Yos Sudarso Kav. 89

Registration Date

Nov 19, 2019

Expiry Date

Aug 10, 2024

Product Type

Clinical Chemistry Test System

Human chorionic gonadotropin (HCG) test system (strip & midstream)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing