Breathing Mask - Vietnam Registration 240002238/PCBB-HCM

Access comprehensive regulatory information for Breathing Mask in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002238/PCBB-HCM and manufactured by Fisher & Paykel Healthcare. The authorized representative in Vietnam is CÔNG TY TNHH ASIA ACTUAL VIETNAM.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including ResMed Pty Ltd, BMC Medical Co Ltd, and 5 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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240002238/PCBB-HCM

Registration Details

Vietnam MOH Registration: 240002238/PCBB-HCM

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Device Details

Breathing Mask

VN: Mặt nạ thở

Risk Class TBYT Loại B

Registration Details

Analysis ID

240002238/PCBB-HCM

Submission ID

000.00.19.H29-240925-0018

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

The Fisher & Paykel Healthcare individual patient masks are designed to be used as an accessory to the ventilator to enable non-invasive positive pressure ventilation (NPPV) (Continuous Positive Airway Pressure (CPAP) or two-level positive airway pressure) to be provided to spontaneously breathing adult patients (>30 kg) with respiratory failure or respiratory failure who have been prescribed NPPV. The masks must be fitted and the therapy must be maintained by trained medical doctors in a hospital/organisation setting with patient monitoring