i-STAT Alinity System and Accessories - Indonesia BPOM Medical Device Registration
i-STAT Alinity System and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101910024. The device is manufactured by ABBOTT POINT OF CARE, INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. TRANSMEDIC 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.
Risk Classification
Product Class
Kelas : 2
Manufacturer
ABBOTT POINT OF CARE, INC.Country of Origin
United States
Authorized Representative
PT. TRANSMEDIC INDONESIAAR Address
PERKANTORAN MENARA ERA UNIT G-01, JL. SENEN RAYA NO. 135-137
Registration Date
Sep 12, 2023
Expiry Date
Jul 01, 2027
Product Type
Clinical Chemistry Test System
Blood gases (P CO 2, P O 2) and blood pH test system
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