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Ketostix Reagent Strips - Indonesia BPOM Medical Device Registration

Ketostix Reagent Strips is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101126759. The device is manufactured by KIMBALL ELECTRONICS POLAND SP. ZO.O. from Poland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. TWO NI ROHA.

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 : C
Ketostix Reagent Strips
Analysis ID: AKL 20101126759

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Poland

Authorized Representative

PT. TWO NI ROHA

AR Address

Satrio Tower Building Lantai 22-24 Jalan Prof. Dr. Kav C4 No 5 Kuningan Timur Setia Budi - Jakarta Selatan 12950

Registration Date

Nov 09, 2021

Expiry Date

Dec 31, 2025

Product Type

Clinical Chemistry Test System

Glucose test system (strip & midstream)

Invitro Diagnostics

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