Pure Global

GEA HCG One Step Pregnancy Strip Test - Indonesia BPOM Medical Device Registration

GEA HCG One Step Pregnancy Strip Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101818883. The device is manufactured by ZHEJIANG ORIENT GENE BIOTECH CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. MEGA PRATAMA MEDICALINDO.

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
GEA HCG One Step Pregnancy Strip Test
Analysis ID: AKL 20101818883

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

China

Authorized Representative

PT. MEGA PRATAMA MEDICALINDO

AR Address

Jl. Pluit Raya 133 Blok A.3

Registration Date

Sep 15, 2021

Expiry Date

Sep 14, 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