Singapore HSA registration DE0010491

Respironics EverFlo, Oxygen Concentrator

Singapore flagSingapore·CLASS B·Respironics, Inc.·Registered September 10, 2012
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90192000
Registration information
Registration Number
DE0010491
Registration Date
September 10, 2012
Change Notification Approval Date
July 02, 2024
Retention Due Date
September 09, 2025
Product description
Intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.
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
2 KALLANG PUDDING ROAD, MACTECH BUILDING, #05-08, SINGAPORE 349307 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)
Everflo Everflo Compressor Intake Filter Humidifer connector tube Micro Disk Filter Flow Meter Locking Kit Air Inlet Filters Stand- alone Pediatric Flow Meter Integrated Pediatric Flow Meter Caster Brake Kit
Model Identifier(s)
1020006 1020008 1020097 1039642 520 528 900- 152 H537- 1 H644 H649
About this record

Access comprehensive regulatory information for Respironics EverFlo, Oxygen Concentrator in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010491 and owned by Respironics, Inc.. The device was registered on September 10, 2012.

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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