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PATHFAST™ hs-cTnI - Indonesia BPOM Medical Device Registration

PATHFAST™ hs-cTnI is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101915557. The device is manufactured by NIPRO CORPORATION ODATE FAMILY 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.

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BPOM Registered
Risk Class Kelas Resiko : B
PATHFAST™ hs-cTnI
Analysis ID: AKL 20101915557

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Japan

Authorized Representative

PT. NUSANTARA BINA DIAGNOSTIKA

AR Address

Pertokoan Bali View No. 35 Jl. Rajawali Pisangan Ciputat, Tangerang Selatan

Registration Date

Jun 04, 2023

Expiry Date

Oct 01, 2025

Product Type

Clinical Chemistry Test System

Creatine phosphokinase/creatine kinase or isoenzymes test system(kit & cair)

Invitro Diagnostics

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