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Singapore HSA registration DE0504457

Respironics AF541 EE Leak 2 Oro-Nasal Mask

Singapore flagSingapore·CLASS B·Respironics, Inc.·Registered May 12, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0504457
Registration Date
May 12, 2020
Retention Due Date
May 11, 2026
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 and single patient use in the home. The mask is to be used on patients (>40lbs/20kg) for whom CPAP or bi-level therapy has been prescribed.
Product Owner
Name
Respironics, Inc.
Short Name
Respironics, Inc.
Address
1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model information
Model Name(s)
S AF541 EE Leak 2, 4PT HDG M AF541 EE Leak 2, 4PT HDG L AF541 EE Leak 2, 4PT HDG XL AF541 EE Leak 2, 4PT HDG S AF541 EE Leak 2, Capstrap M AF541 EE Leak 2, Capstrap L AF541 EE Leak 2, Capstrap XL AF541 EE Leak 2,Capstrap RP, AF541 Sizing Gauge ACC, Bronchoscopy Elbow, Click Style ACC, Bronchoscopy Elbow, Click Style XS AF541 EE Leak 2 Under the Nose, 4PT HDG A AF541 EE Leak 2 Under the Nose, 4PT HDG B AF541 EE Leak 2 Under the Nose, 4PT HDG C AF541 EE Leak 2 Under the Nose, 4PT HDG XS AF541 EE Leak 2 Under the Nose, Capstrap A AF541 EE Leak 2 Under the Nose, Capstrap B AF541 EE Leak 2 Under the Nose, Capstrap C AF541 EE Leak 2 Under the Nose, Capstrap
Model Identifier(s)
1120930 1120931 1120932 1120933 1120935 1120936 1120937 1120938 1120977 1120984 1121442 1133672 1133673 1133674 1133675 1133676 1133677 1133678 1133679
About this record

Access comprehensive regulatory information for Respironics AF541 EE Leak 2 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 DE0504457 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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