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ALINITY i Galectin-3 Calibrators - Indonesia BPOM Medical Device Registration

ALINITY i Galectin-3 Calibrators is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101124737. The device is manufactured by FUJIREBIO DIAGNOSTICS INC from United States, 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
ALINITY i Galectin-3 Calibrators
Analysis ID: AKL 20101124737

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. ABBOTT PRODUCTS INDONESIA

AR Address

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

Registration Date

Nov 16, 2023

Expiry Date

Apr 26, 2028

Product Type

Clinical Chemistry Test System

Calibrator (cair)

Invitro Diagnostics

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