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 20101422475. 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.
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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
Dec 02, 2024
Expiry Date
Dec 01, 2027
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (strip & midstream)
Invitro Diagnostics
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