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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. MEGA PRATAMA MEDICALINDOAR 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
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