Pure Global

Respironics AF541 SE Oro-Nasal Mask - HSA Registration DE0504456

Access comprehensive regulatory information for Respironics AF541 SE Oro-Nasal 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 DE0504456 and owned by Respironics, Inc.. The device was registered on May 12, 2020.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0504456
Respironics AF541 SE Oro-Nasal Mask
HSA Registration Number: DE0504456
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

This mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) who are appropriate candidates for noninvasive ventilation.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504456
Registration Date
May 12, 2020
Retention Due Date
May 11, 2026
Product Owner
Short Name
Respironics, Inc.
Address
1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model Information
Model Name(s)
S AF541 SE, 4PT HDG M AF541 SE, 4PT HDG L AF541 SE, 4PT HDG XL AF541 SE, 4PT HDG S AF541 SE, Capstrap M AF541 SE, Capstrap L AF541 SE, Capstrap XL AF541 SE, Capstrap ACC, Bronchoscopy Elbow, Click Style ACC, Bronchoscopy Elbow, Click Style XS AF541 SE Under the Nose, 4PT HDG A AF541 SE Under the Nose, 4PT HDG B AF541 SE Under the Nose, 4PT HDG C AF541 SE Under the Nose, 4PT HDG XS AF541 SE Under the Nose, CapStrap A AF541 SE Under the Nose, Capstrap B AF541 SE Under the Nose, Capstrap C AF541 SE Under the Nose, Capstrap
Model Identifier(s)
1120940 1120941 1120942 1120943 1120945 1120946 1120947 1120948 1120984 1121442 1133680 1133681 1133682 1133683 1133684 1133685 1133686 1133687