Singapore HSA registration DE0019338
Respironics InnoSpire Go Portable Mesh Nebulizer
Singapore·CLASS B·Respironic Respiratory Drug Delivery (UK)·Registered June 15, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0019338
- Registration Date
- June 15, 2017
- Change Notification Approval Date
- January 31, 2019
- Retention Due Date
- June 14, 2025
Product description
The InnoSpire Go is a general purpose mesh nebulizer that is intended to be used to nebulize commonly prescribed liquid inhaled medications for respiratory disease. It is intended for single patient use, to deliver multiple doses. It is to be used by patients from infant to adult. It is suitable for use in the home environment, but may also be used in a hospital/clinic setting. It is not to be used by patients that are unconscious or not breathing spontaneously. The patient or the patient’s care giver is the intended operator of the device.
Product Owner
- Short Name
- Respironic Respiratory Drug Delivery (UK)
- Address
- Chichester Business Park, City Field Way, Tangmere, Chischester PO20 2FT, UK, UNITED KINGDOM
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)
- InnoSpire Go Mask Adapter InnoSpire Go InnoSpire Go LiteTouch Medium Mask InnoSpire Go LiteTouch Small Mask InnoSpire Go LiteTouch Large Mask InnoSpire Go Mouthpiece Assembly
- Model Identifier(s)
- 1125985 1126584 1127798 1127822 1127875 1128501
About this record
Access comprehensive regulatory information for Respironics InnoSpire Go Portable Mesh Nebulizer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0019338 and owned by Respironic Respiratory Drug Delivery (UK). The device was registered on June 15, 2017.
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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