Singapore HSA registration DE0504456
Respironics AF541 SE Oro-Nasal Mask
Singapore·CLASS B·Respironics, Inc.·Registered May 12, 2020Device 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 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.
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
About this record
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.
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