← Back to catalogue
Oxygen Concentrator
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref P2-O5EModel P2-O5L，P2-O5E，QOC-5
Identity
- Trade Name
- OXYGEN CONCENTRATOR EUDAMED
- Device Name
- OXYGEN CONCENTRATOR EUDAMED
- Model / Reference
- P2-O5L，P2-O5E，QOC-5 EUDAMEDP2-O5E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971882890451 EUDAMED
- Basic UDI-DI
- 697188289P2-O5M6 EUDAMED
- Direct Marketing DI
- 06971882890451 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa 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 Qingdao Kingon Medical Science and Technology Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251764 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697188289P2-O5M6 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000018407
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 37ce93de-888c-423f-a07e-9ec415193636 61 fields · synced Oct 6, 2026
- FDA 510(k) K251764 1 fields · synced May 18, 2026