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Oxygen Concentrator
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref OX-5BModel OX-5A, OX-5B, OX-5CRef OX-5ARef OX-10BModel OX-10A, OX-10BRef OX-1A-E
Identity
- Trade Name
- Oxygen Concentrator EUDAMED
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- OX-5A, OX-5B, OX-5C EUDAMEDOX-5B EUDAMEDOX-5A EUDAMEDOX-10A, OX-10B EUDAMEDOX-10B EUDAMEDOX-1A-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973632410087 EUDAMED06973632410070 EUDAMED06973632410063 EUDAMED06973632410100 EUDAMED
- Basic UDI-DI
- 697363241007JH EUDAMED697363241005JD EUDAMEDB-06973632410100 EUDAMED
- Direct Marketing DI
- 06973632410087 EUDAMED06973632410070 EUDAMED06973632410063 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDPoland 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 — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252965 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | 697363241007JH | Class IIb | Active |
| 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 (5)
- EUDAMED 7779aca7-a6cc-428c-a06e-308359e3192e 61 fields · synced Jul 21, 2026
- EUDAMED 7b908cc1-6a2e-4221-b4a9-f2b80cbae52f 61 fields · synced May 18, 2026
- EUDAMED ba44e8f1-6aaa-4ff9-b139-8dca1fd819c6 61 fields · synced May 18, 2026
- EUDAMED c3db6ebf-8b2e-4380-ac10-985fa108f377 61 fields · synced May 19, 2026
- FDA 510(k) K252965 1 fields · synced Jun 18, 2026