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ARCHITECT STAT High Sensitive Troponin-I Controls - Indonesia BPOM Medical Device Registration

ARCHITECT STAT High Sensitive Troponin-I Controls is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101020510. The device is manufactured by ABBOTT IRELAND DIAGNOSTICS DIVISION. from Ireland, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is 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 STAT High Sensitive Troponin-I Controls
Analysis ID: AKL 20101020510

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Ireland

Authorized Representative

ABBOTT PRODUCTS INDONESIA

AR Address

Wisma Pondok Indah 2, Suite 1000, Jl. Sultan Iskandar Muda Kav V - TA

Registration Date

Aug 14, 2024

Expiry Date

Jun 17, 2029

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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