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Singapore HSA registration DE0012086

Philips Respironics PerforMax Pediatric SE Total Face Mask [MPU/SU]

Singapore flagSingapore·CLASS B·Philips Respironics, Inc.·Registered January 03, 2013
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration information
Registration Number
DE0012086
Registration Date
January 03, 2013
Retention Due Date
January 02, 2026
Product description
The PerforMax Pediatric SE Total Face 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 ventilator 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 multiple use /single use in the hospital/institutional environment only. The mask is to be used on patients 1 year or older (>7 kg) who are appropriate candidates for noninvasive ventilation.
Product Owner
Name
Philips Respironics, Inc.
Short Name
Philips Respironics, Inc.
Address
1010 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)
XS PerforMax SE, MPU with 4 headgear [2 pink, 2 blue] XXS PerforMax SE, MPU with 4 headgear [2 pink, 2 blue] XS PerforMax SE, SU with headgear [Yellow] XXS PerforMax SE, SU with headgear [Yellow] Headgear Bonnet with clips PerforMax XS/XXS Pediatric 6 Pack [3 Pink, 3 Blue] Sizing Gauge PerforMax XS/XXS Pediatric, 25 Pack Headgear Bonnet with clips PerforMax XS/XXS Pediatric 6 Pack [Yellow] CleanClip Shell XS PerforMax, 9 Pack CleanClip Shell XXS PerforMax, 9 Pack Headgear Bonnet with clips Petite PerforMax Pediatric [3 Pink, 3 Blue] 6 Pack Headgear Bonnet with clips Petite PerforMax Pediatric [Yellow] 6 Pack
Model Identifier(s)
1083085 1083086 1083149 1083150 1083152 1083153 1097304 1099040 1099041 1101909 1101910
About this record

Access comprehensive regulatory information for Philips Respironics PerforMax Pediatric SE Total Face Mask [MPU/SU] in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012086 and owned by Philips Respironics, Inc.. The device was registered on January 03, 2013.

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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