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FREESTYLE Optium Blood β-Ketone Test Strips - Indonesia BPOM Medical Device Registration

FREESTYLE Optium Blood β-Ketone Test Strips is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101810475. The device is manufactured by ABBOTT DIABETES CARE LTD. from United Kingdom, 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
FREESTYLE Optium Blood β-Ketone Test Strips
Analysis ID: AKL 20101810475

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United Kingdom

Authorized Representative

PT. ABBOTT PRODUCTS INDONESIA

AR Address

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

Registration Date

Jul 30, 2024

Expiry Date

Aug 10, 2027

Product Type

Clinical Chemistry Test System

Ketones (nonquantitative) test system (strip & midstream)

Invitro Diagnostics

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