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I-STAT 1 Analyzer 300-G and Accessories - Indonesia BPOM Medical Device Registration

I-STAT 1 Analyzer 300-G and Accessories is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101410697. The device is manufactured by FLEXTRONIC MANUFACTURING (SINGAPORE) PTE, LTD. from Singapore, 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.

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BPOM Registered
Risk Class Kelas Resiko : B
I-STAT 1 Analyzer 300-G and Accessories
Analysis ID: AKL 20101410697

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Singapore

Authorized Representative

PT. TRANSMEDIC INDONESIA

AR 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

Invitro Diagnostics

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