Identity
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- AI-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970379850435 EUDAMED
- Basic UDI-DI
- B-06970379850435 EUDAMED
- EMDN Code
- Z12159004 OXYGEN CONCENTRATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Oxygen Concentrator by Foshan MIC Medical Technology Co., LTD. — Class IIa — FDA_510K, MDD — listed in EUDAMED, 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 | K202389 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06970379850435 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foshan MIC Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000027750
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (2)
- EUDAMED 762ca21a-6ad3-49d0-b351-f0417bee899c 61 fields · synced Jun 19, 2026
- FDA 510(k) K202389 1 fields · synced May 18, 2026