Quality Access® HCG Test Strip (Urine) - Indonesia BPOM Medical Device Registration
Quality Access® HCG Test Strip (Urine) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101422265. The device is manufactured by NANTONG EGENS BIOTECHNOLOGY CO., LTD. from China, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. BUANA MITRA SUKSES.
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
NANTONG EGENS BIOTECHNOLOGY CO., LTD.Country of Origin
China
Authorized Representative
PT. BUANA MITRA SUKSESAR Address
RUKO NIAGA KALIMAS I BLOK B 10-11 JL INSPEKSI KALIMALANG
Registration Date
Nov 01, 2024
Expiry Date
Aug 08, 2026
Product Type
Clinical Chemistry Test System
Human chorionic gonadotropin (HCG) test system (strip & midstream)
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