ADVIA Centaur Insulin (IRI) - Indonesia BPOM Medical Device Registration

ADVIA Centaur Insulin (IRI) is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101220589. The device is manufactured by MINARIS MEDICAL CO., LTD. from Japan, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. SIEMENS HEALTHINEERS 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

ADVIA Centaur Insulin (IRI)

Analysis ID: AKL 20101220589

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

MINARIS MEDICAL CO., LTD.

Country of Origin

Japan

Authorized Representative

PT. SIEMENS HEALTHINEERS INDONESIA

AR Address

Perkantoran Hijau Arkadia Tower F, Lantai 18, Jl.Tahi Bonar Simatupang Kav. 88

Registration Date

Feb 07, 2025

Expiry Date

Apr 01, 2029

Product Type

Clinical Chemistry Test System

Immunoreactive insulin test system (kit & cair)

Invitro Diagnostics

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MedTech Regulatory Expert

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Other Products from MINARIS MEDICAL CO., LTD.

Products from the same manufacturer (4 products)

ADVIA Centaur Insulin Calibrator (IRI CAL)

Kelas Resiko : B

ADVIA Centaur C-Peptide Calibrator

Kelas Resiko : B

ADVIA Centaur Insulin Diluent (IRI DIL)

Kelas Resiko : A

ADVIA Centaur C-peptide (CpS)

Kelas Resiko : B

Other Products from PT. SIEMENS HEALTHINEERS INDONESIA

Products with the same authorized representative (10 products)

DIMENSION Revised C-Reactive Protein Calibrator (RCRP CAL)

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

ADVIA Centaur Calibrator D

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Kelas Resiko : B

IMMULITE 2000 Systems Allergen Specific IgE Universal Kit

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Kelas Resiko : B

IMMULITE 2000 3gAllergy Specific IgE Positive Control for D1 &D2

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Kelas Resiko : B

ADVIA Centaur Anti-HBs2 Quality Control (aHBs2 QC)

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Kelas Resiko : B

DIMENSION Bilirubin Calibrator (TBI/DBI CAL)

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

ADVIA Centaur CA 15-3

SIEMENS HEALTHCARE DIAGNOSTICS INC. (WALPOLE)

Kelas Resiko : C

CLINITEK Status+ Analyzer and Accessories

SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD.

Kelas Resiko : B

DIMENSION CHOL Flex Reagent Cartridge.

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

RAPIDQC Complete Level 1

BIONOSTICS, INC.

Kelas Resiko : B