Identity
- Trade Name
- PORTABLE OXYGEN CONCENTRATOR EUDAMED
- Device Name
- PORTABLE OXYGEN CONCENTRATOR EUDAMED
- Model / Reference
- P2-TOC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971882890444 EUDAMED
- Basic UDI-DI
- 697188289P2-TOCNV EUDAMED
- Direct Marketing DI
- 06971882890444 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
Portable 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-TOCNV | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018407
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 0aa7b06f-f66b-441c-a765-9c3080065b45 61 fields · synced Oct 5, 2026