ONEHEALTH HCG One Step Pregnancy Cassette Test - Indonesia BPOM Medical Device Registration
ONEHEALTH HCG One Step Pregnancy Cassette Test is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101220419. 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. MEDICAL ERA ALKESINDO.
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Risk Classification
Product Class
Kelas : 2
Manufacturer
ZHEJIANG ORIENT GENE BIOTECH CO., LTD.Country of Origin
China
Authorized Representative
PT. MEDICAL ERA ALKESINDOAR Address
Jl. Makmur 88 P, Kompleks Cemara Asri
Registration Date
Mar 31, 2022
Expiry Date
Mar 31, 2025
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system
Invitro Diagnostics
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