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oxygen concentrator
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 308056Model MQ50
Identity
- Trade Name
- oxygen concentrator EUDAMEDFDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- OXYGEN CONCENTRATOR EUDAMED
- Model / Reference
- MQ50 EUDAMEDFDA UDI308056 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06955623000033 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06955623000033 EUDAMED
- 510(k) Number
- K172234 FDA UDI
- FDA Product Code
- CAW FDA UDI
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
- GMDN Term
- Stationary oxygen concentrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5440 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
MR Safe FDA UDI
oxygen concentrator by Sysmed (china) Co., Ltd — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172234 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06955623000033 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SysMed (China) Co., Ltd.
- EUDAMED SRN
- CN-MF-000011904
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (3)
- EUDAMED efebc8a4-4738-4c0e-94f9-26da3fd445ac 61 fields · synced Jul 21, 2026
- FDA UDI 17a501ad-091b-47f2-86b0-b3d46a71e58d 33 fields · synced May 30, 2026
- FDA 510(k) K172234 1 fields · synced May 18, 2026