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Respironics SimplyGo Mini Portable Oxygen Concentrator - HSA Registration DE0018748

Access comprehensive regulatory information for Respironics SimplyGo Mini Portable 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 DE0018748 and owned by Respironics, Inc. The device was registered on November 23, 2016.

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
DE0018748
Respironics SimplyGo Mini Portable Oxygen Concentrator
HSA Registration Number: DE0018748
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Product Description

Respironics SimplyGo Mini Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel/mobile environments.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0018748
Registration Date
November 23, 2016
Change Notification Approval Date
October 25, 2024
Retention Due Date
November 22, 2025
Product Owner
Short Name
Respironics, Inc
Address
1001 Murry Ridge Lane, Murrysville PA 15668-8550, 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 6 TAGORE DRIVE, TAGORE INDUSTRIAL BUILDING, #03-11, SINGAPORE 787623 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)
SimplyGo Mini with Standard Battery, INTL SimplyGo Mini with Extended Battery, INTL SimplyGo Mini, Standard Battery Kit SimplyGo Mini, Extended Battery Kit
Model Identifier(s)
1113604 1113605 1116816 1116817