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Portable Oxygen Concentrator
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref P2-S3Model P2-K3 P2-K4 P2-S3 P2-S4
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-K3 P2-K4 P2-S3 P2-S4 EUDAMEDP2-S3 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971882890475 EUDAMED06971882890222 FDA UDI
- Basic UDI-DI
- 697188289P2-K/SKK EUDAMED
- Direct Marketing DI
- 06971882890475 EUDAMED
- 510(k) Number
- K230702 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, 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 | K190304 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697188289P2-K/SKK | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000018407
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED ba185e9b-1df1-4ee6-89af-f8331310fdd4 61 fields · synced Oct 6, 2026
- FDA UDI 049bb191-8a49-49f0-bc6d-2ff90916424b 33 fields · synced May 29, 2026
- FDA 510(k) K190304 1 fields · synced May 18, 2026