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INFINIUM OMNI II Patient Monitor - Indonesia BPOM Medical Device Registration

INFINIUM OMNI II Patient Monitor is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20502010186. The device is manufactured by INFINIUM MEDICAL INC. from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. INDOPRIMA BIONET.

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BPOM Registered
Risk Class Kelas Resiko : B
INFINIUM OMNI II Patient Monitor
Analysis ID: AKL 20502010186

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

United States

Authorized Representative

PT. INDOPRIMA BIONET

AR Address

Jl. Taman Sari Raya, No. 56B, Tamansari

Registration Date

Oct 25, 2024

Expiry Date

Jun 26, 2029

Product Type

Monitoring Cardiology Equipment

Cardiac monitor (including cardiotachometer and rate alarm).

Non Radiation Electromedics

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