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DeVilbiss CPAPs - HSA Registration DE0505165

Access comprehensive regulatory information for DeVilbiss CPAPs in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505165 and owned by DeVilbiss Healthcare, LLC.. The device was registered on November 23, 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
DE0505165
DeVilbiss CPAPs
HSA Registration Number: DE0505165
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Product Description

The DeVilbiss is intended for use in treating OSA in spontaneously breathing patients 30 Kg (66 lbs) and above by means of application of positive air pressure.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0505165
Registration Date
November 23, 2020
Retention Due Date
November 22, 2025
Product Owner
Short Name
DeVilbiss Healthcare, LLC.
Address
100 DeVilbiss Drive Somerset, PA 15501, UNITED STATES
Registrant
Address
111 SOMERSET ROAD, 111 SOMERSET, #04-26, SINGAPORE 238164
Importer
Address
111 SOMERSET ROAD, 111 SOMERSET, #04-26, SINGAPORE 238164
Model Information
Model Name(s)
SleepCube Standard SleepCube Standard Plus SleepCube Auto Adjust SleepCube BiLevel S SleepCube BiLevel ST SleepCube Auto BiLevel DeVilbiss Heater, Humidifier DV63 Series Standard Plus CPAP DV64 Series AutoPlus CPAP DV6 Series Heated Humidifier
Model Identifier(s)
DV51UK DV53UK DV54UK DV55UK DV56UK DV57UK DV5HH DV63E-UK DV64E-UK DV6HH