Identity
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- AII-5 EUDAMEDCP501 EUDAMEDCP101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970379850411 EUDAMED06970379850404 EUDAMED06970379850152 EUDAMED
- Basic UDI-DI
- B-06970379850411 EUDAMEDB-06970379850404 EUDAMEDB-06970379850152 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 — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970379850411 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan MIC Medical Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000027750
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED 84c518f8-e58b-4819-86f1-b992b9c6e99e 61 fields · synced Oct 7, 2026
- EUDAMED 638b8268-8913-4305-9aba-f6af14c5872d 61 fields · synced May 16, 2026
- EUDAMED e692d42c-0a2e-4eca-81be-766b55a7d3a0 61 fields · synced May 17, 2026