Portable Oxygen Concentrator
by Qingdao Kingon Medical Science and Technology Co., Ltd. EUDAMED
Active
Ref P2-EModel P2-E,P2-E6,P2-E7
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberFI25/1008016 | Date28 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- FI25/1008016 Supplemented
Quality management system EU MDR
- Notified body
- SGS FIMKO OY 0598
- Issued
- 28 Aug 2026
- Expires
- 5 Jun 2030
- Reason
- Other
Specification
- Model / Reference
- P2-E, P2-E6, P2-E7
- Primary DI / UDI-DI
- 06971882890390
- Basic UDI-DI
- 697188289P2-ENU
- Direct Marketing DI
- 06971882890390
- EMDN Code
- Z12159004 Oxygen concentrators
- Device Class
- Class IIa
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000018407
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No