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FLOW-SAFE II Disposable CPAP System - Indonesia BPOM Medical Device Registration

FLOW-SAFE II Disposable CPAP System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20403810108. The device is manufactured by PLAXTRON INDUSTRIAL (M) SDN., BHD. from Malaysia, and is classified as Risk Class Kelas Resiko : C. The authorized representative in Indonesia is PT. AMPM HEALTHCARE 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 : C
FLOW-SAFE II Disposable CPAP System
Analysis ID: AKL 20403810108

Risk Classification

Kelas Resiko : C

Product Class

Kelas : 2

Country of Origin

Malaysia

Authorized Representative

PT. AMPM HEALTHCARE INDONESIA

AR Address

Jl.Cengkeh Kav.16 No.29-30

Registration Date

Oct 25, 2023

Expiry Date

Apr 18, 2025

Product Type

Therapeutic Anesthesia Equipment

Noncontinuous ventilator (IPPB).

Non Electromedic Non Sterile

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