PATHFAST Presepsin - Indonesia BPOM Medical Device Registration
PATHFAST Presepsin is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20303220195. The device is manufactured by NIPRO CORPORATION ODATE FACTORY from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. NUSANTARA BINA DIAGNOSTIKA.
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
NIPRO CORPORATION ODATE FACTORYCountry of Origin
Japan
Authorized Representative
PT. NUSANTARA BINA DIAGNOSTIKAAR Address
Pertokoan Bali View No. 35 Jl. Rajawali Pisangan Ciputat, Tangerang Selatan
Registration Date
Jun 01, 2023
Expiry Date
Oct 13, 2025
Product Type
Serological Reagents
Endotoxin assay.
Invitro Diagnostics
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