Fisher & Paykel Nivairo™ Hospital Full Face Mask - HSA Registration DE0505514
Access comprehensive regulatory information for Fisher & Paykel Nivairo™ Hospital Full Face Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505514 and owned by Fisher & Paykel Healthcare Ltd.. The device was registered on March 01, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Fisher & Paykel Healthcare single patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.