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Portable Oxygen Concentrator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P2-E6Model P2-E,P2-E6,P2-E7
Identity
- Trade Name
- PORTABLE OXYGEN CONCENTRATOR EUDAMEDRhythm Healthcare FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Portable Oxygen Concentrator EUDAMED
- Model / Reference
- P2-E,P2-E6,P2-E7 EUDAMEDP2-E6 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971882890406 EUDAMED06971882890093 FDA UDI
- Basic UDI-DI
- 697188289P2-ENU EUDAMED
- Direct Marketing DI
- 06971882890406 EUDAMED
- 510(k) Number
- K210371 FDA UDI
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Portable Oxygen Concentrator by Qingdao Kingon Medical Science and Technology Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697188289P2-ENU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018407
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED ade8da00-6d70-48df-bbc6-75a78a0cb299 61 fields · synced Oct 6, 2026
- FDA UDI b00e7f80-2e71-4688-86e4-c34623527afe 33 fields · synced May 29, 2026