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ARCHITECT CK-MB - Indonesia BPOM Medical Device Registration

ARCHITECT CK-MB is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101110210. The device is manufactured by SENTINEL CH SPA. from Italy, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. ABBOTT PRODUCTS INDONESIA.

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
ARCHITECT CK-MB
Analysis ID: AKL 20101110210

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

SENTINEL CH SPA.

Country of Origin

Italy

Authorized Representative

PT. ABBOTT PRODUCTS INDONESIA

AR Address

WISMA PONDOK INDAH 2 SUITE 1000, JL. SULTAN ISKANDAR MUDA KAV. V-TA

Registration Date

Jan 31, 2022

Expiry Date

Jun 03, 2026

Product Type

Clinical Chemistry Test System

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

Invitro Diagnostics

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