Breathing Mask
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Fisher & Paykel Healthcare·Registered Oct 01, 2024- Analysis ID
- 240002238/PCBB-HCM
- Submission ID
- 000.00.19.H29-240925-0018
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Fisher & Paykel Healthcare
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Fisher & Paykel Healthcare
- Authorized Representative
- CÔNG TY TNHH ASIA ACTUAL VIETNAM
- 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
- Registration Date
- Oct 01, 2024
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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.