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CARESCAPE B450 - Indonesia BPOM Medical Device Registration

CARESCAPE B450 is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20501916186. The device is manufactured by GE HEALTHCARE FINLAND OY. from Finland, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. GE OPERATIONS INDONESIA.

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BPOM Registered
Risk Class Kelas Resiko : C
CARESCAPE B450
Analysis ID: AKL 20501916186

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Finland

Authorized Representative

PT. GE OPERATIONS INDONESIA

AR Address

South Quarter Tower B, Lantai 18-19 Jl. R.A. Kartini, Kav. 8 Kel. Cilandak Barat, Kec. Cilandak Jakarta Selataran 12430

Registration Date

Sep 19, 2019

Expiry Date

Dec 13, 2023

Product Type

Diagnostic Cardiology Equipment

Arrhythmia detector and alarm (including ST-segment measurement and alarm).

Non Radiation Electromedics

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