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Respironics Nuance Gel Pillows Mask - HSA Registration DE0016081

Access comprehensive regulatory information for Respironics Nuance Gel Pillows 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 DE0016081 and owned by Respironics, Inc.. The device was registered on August 04, 2014.

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
DE0016081
Respironics Nuance Gel Pillows Mask
HSA Registration Number: DE0016081
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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 patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0016081
Registration Date
August 04, 2014
Retention Due Date
August 03, 2025
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
25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 3 MOUNT ELIZABETH, MOUNT ELIZABETH HOSPITAL, #12-13, SINGAPORE 228510 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763 2 JALAN RAJAH, GOLDEN WALL FLATTED FACTORY, #05-20, SINGAPORE 329134 246 MACPHERSON ROAD, BETIME BUILDING, #03-01, SINGAPORE 348578
Model Information
Model Name(s)
Nuance Gel Pillows Mask, w/Hgr , INTL Nuance Pro Gel Pillows Mask, w/Hgr, INTL S Nuance/Nuance Pro Gel Pillows Cushion RP M Nuance/Nuance Pro Gel Pillows Cushion RP L Nuance/Nuance Pro Gel Pillows Cushion RP Nuance Headgear, RP Nuance Fabric Frame, RP Nuance Pro Headgear, RP Nuance Pro Frame, RP Nuance/Nuance Pro Swivel Tube w/ Exhalation RP Nuance RS Fabric Frame, RP
Model Identifier(s)
1105161 1105168 1105173 1105174 1105175 1105176 1105177 1105178 1105179 1105180 1105405