Pure Global

FiCA cTnI - Indonesia BPOM Medical Device Registration

FiCA cTnI is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101520056. The device is manufactured by SURE BIO-TECH (USA) CO., LTD from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOLAB ARTHA MEDIKA.

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.

Free Database
Powered by Pure Global AI
BPOM Registered
Risk Class Kelas Resiko : B
FiCA cTnI
Analysis ID: AKL 20101520056

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. INDOLAB ARTHA MEDIKA

AR Address

Komp Ruko Sunter Paradise Tahap II Blok.A4 No.43. Sunter Agung Podomoro

Registration Date

Jan 08, 2025

Expiry Date

Jan 30, 2029

Product Type

Clinical Chemistry Test System

Creatine phosphokinase/creatine kinase or isoenzymes test system (card)

Invitro Diagnostics

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing