AI-Rad Companion Brain MR - Indonesia BPOM Medical Device Registration

AI-Rad Companion Brain MR is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21501321414. The device is manufactured by SIEMENS HEALTHCARE GMBH from Germany, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is 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.

Free Database

Powered by Pure Global AI

BPOM Registered

Risk Class Kelas Resiko : C

AI-Rad Companion Brain MR

Analysis ID: AKL 21501321414

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Manufacturer

SIEMENS HEALTHCARE GMBH

Country of Origin

Germany

Authorized Representative

SIEMENS HEALTHINEERS INDONESIA

AR Address

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

Registration Date

Nov 28, 2023

Expiry Date

Mar 27, 2028

Product Type

Diagnostic Radiology Equipment

Medical image management and processing system.

Non Radiation Electromedics

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Other Products from SIEMENS HEALTHCARE GMBH

Products from the same manufacturer (6 products)

AI-Rad Companion Chest X-ray

Kelas Resiko : C

AI-Rad Companion Chest X-ray

Kelas Resiko : B

ARCADIS Orbic

Kelas Resiko : C

ARCADIS Avantic

Kelas Resiko : C

ARCADIS Varic

Kelas Resiko : C

SIEMENS AI-RAD COMPANION

Kelas Resiko : B

Other Products from SIEMENS HEALTHINEERS INDONESIA

Products with the same authorized representative (10 products)

DIMENSION Creatinine Flex reagent cartridge (CRE2)

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

DIMENSION Clinical Chemistry System Flex Reagent Cartridge PCHE.

SIEMENS HEALTHCARE DIAGNOSTICS INC. (NEWARK)

Kelas Resiko : A

IMMULITE 2000 Systems GRH Growth Hormone

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.

Kelas Resiko : B

IMMULITE 2000 Substrate Module 2000T

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : A

DIMENSION GGT Flex Reagent Cartridge

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

Dimension Automated HDL Cholesterol Flex (AHDL)

SIEMENS HEALTHCARE DIAGNOSTICS INC

Kelas Resiko : B

Dimension Alkaline Phosphatase Calibrator ( ALPI CAL )

SIEMENS HEALTHCARE DIAGNOSTICS INC

Kelas Resiko : B

DIMENSION MBI Flex reagent cartridge

SIEMENS HEALTHCARE DIAGNOSTICS INC.

Kelas Resiko : B

ADVIA Centaur VB12 Diluent Ready Pack

SIEMENS HEALTHCARE DIAGNOSTICS INC. (EAST WALPOLE)

Kelas Resiko : B

DIMENSION Magnesium Flex (MG)

SIEMENS HEALTHCARE DIAGNOSTICS INC

Kelas Resiko : B