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O2matic O2matic Pro 100 - HSA Registration DE0508237

Access comprehensive regulatory information for O2matic O2matic Pro 100 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508237 and owned by O2matic Aps. The device was registered on June 26, 2023.

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 C
DE0508237
O2matic O2matic Pro 100
HSA Registration Number: DE0508237
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Product Description

O2matic PRO 100 is an electro/mechanical medical device, intended for oxygen therapy optimization at all hospital departments and units that administer oxygen therapy. O2matic PRO 100 is for short term continuous use at hospital for not more than 30 days. The regulation of oxygen is managed by a software algorithm.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0508237
Registration Date
June 26, 2023
Retention Due Date
June 25, 2025
Product Owner
Short Name
O2matic Aps
Address
Noerrelundvej 10, 2730 Herlev, DENMARK
Registrant
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832
Importer
Address
82 UBI AVENUE 4, EDWARD BOUSTEAD CENTRE, #08-01, SINGAPORE 408832 37 UBI CRESCENT, SINGAPORE 408586
Model Information
Model Name(s)
Adult Articulated Finger Clip Pulse Oximeter Sensor 1M Ext Cable Ear Clip Pulse Oximeter Sensor Reusable Soft Pulse Oximeter Sensors Reusable Soft Pulse Oximeter Sensors Reusable Soft Pulse Oximeter Sensors Adult Disposable Single-Patient Use Pulse Oximeter Sensor Adult Disposable Single-Patient Use Pulse Oximeter Sensor PRO 100
Model Identifier(s)
3278-003 6083-001 6455-000 6835-300 6836-300   6837-300 7426-001 7427-001 PRO 100