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Respironics AF541 EE Leak 1 Oro-Nasal Mask - HSA Registration DE0504458

Access comprehensive regulatory information for Respironics AF541 EE Leak 1 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 DE0504458 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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CLASS B
DE0504458
Respironics AF541 EE Leak 1 Oro-Nasal Mask
HSA Registration Number: DE0504458
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Product Description

This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single use in the hospital/institutional environment only. The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504458
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 EE Leak 1, 4PT HDG, INTL M AF541 EE Leak 1, 4PT HDG, INTL L AF541 EE Leak 1, 4PT HDG, INTL XL AF541 EE Leak 1, 4PT HDG, INTL S AF541 EE Leak 1, Capstrap, INTL M AF541 EE Leak 1, Capstrap, INTL L AF541 EE Leak 1, Capstrap, INTL XL AF541 EE Leak 1, Capstrap, INTL ACC, Bronchoscopy Elbow, Click Style ACC, Bronchoscopy Elbow, Click Style XS AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL A AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL B AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL C AF541 EE Leak 1 Under the Nose, 4PT HDG, INTL XS AF541 EE Leak 1 Under the Nose, Capstrap, INTL A AF541 EE Leak 1 Under the Nose, Cpastrap, INTL B AF541 EE Leak 1 Under the Nose, Capstrap, INTL C AF541 EE Leak 1 Under the Nose, Capstrap, INTL
Model Identifier(s)
1120920 1120921 1120922 1120923 1120925 1120926 1120927 1120928 1120984 1121442 1133664 1133665 1133666 1133667 1133668 1133669 1133670 1133671