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Oxygen Concentrator
EUDAMEDClass IIb (EU MDR)
Ref OX-5CModel OX-5A, OX-5B, OX-5C
Identity
- Trade Name
- Oxygen Concentrator EUDAMED
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- OX-5A, OX-5B, OX-5C EUDAMEDOX-5C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973632410124 EUDAMED
- Basic UDI-DI
- 697363241007JH EUDAMED
- Direct Marketing DI
- 06973632410124 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oxygen Concentrator by Oxytek Medical Technology Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697363241007JH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Oxytek Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000022935
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 1f19a357-6f38-431a-8ada-105675e3dc28 61 fields · synced Jun 19, 2026