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PATHFAST hsCRP - Indonesia BPOM Medical Device Registration

PATHFAST hsCRP is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20305220080. 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.

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BPOM Registered
Risk Class Kelas Resiko : B
PATHFAST hsCRP
Analysis ID: AKL 20305220080

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

May 28, 2023

Expiry Date

Oct 13, 2025

Product Type

Immunological Test System

C-reactive protein immunological test system.

Invitro Diagnostics

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DJ Fang

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