Pure Global

HUBI Cardiac DUO (TnI/CK-MB) - Indonesia BPOM Medical Device Registration

HUBI Cardiac DUO (TnI/CK-MB) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101914503. The device is manufactured by HUMASIS CO., LTD. from Korea, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOCORE PERKASA.

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
HUBI Cardiac DUO (TnI/CK-MB)
Analysis ID: AKL 20101914503

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

HUMASIS CO., LTD.

Country of Origin

Korea

Authorized Representative

PT. INDOCORE PERKASA

AR Address

Komplek Graha Mas Pemuda Blok AB No. 19, Jl. Pemuda RT 020 / RW 006 Kel. Jati, Kec. Pulo Gadung, Jakarta Timur, DKI Jakarta

Registration Date

Jan 19, 2021

Expiry Date

Nov 18, 2025

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