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Oxygen Concentrator
EUDAMEDClass IIa (EU MDR)
Ref QOC-5Model 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 EUDAMEDQOC-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971882891151 EUDAMED
- Basic UDI-DI
- 697188289P2-O5M6 EUDAMED
- Direct Marketing DI
- 06971882891151 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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 — 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 | 697188289P2-O5M6 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018407
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 3d2342e8-f4a2-4cc6-ad12-0d448b84b38b 61 fields · synced Oct 6, 2026