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Oxygen Concentrator
EUDAMEDClass IIa (EU MDR)
Ref FDOC6110Ref FDOC6905Ref FDOC6210Ref FDOC6405Ref FDOC6305
Identity
- Trade Name
- Oxygen Concentrator EUDAMED
- Device Name
- Oxygen Concentrator EUDAMED
- Model / Reference
- FDOC6110 EUDAMEDFDOC6905 EUDAMEDFDOC6210 EUDAMEDFDOC6405 EUDAMEDFDOC6305 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970389630164 EUDAMED06970389630720 EUDAMED06970389639907 EUDAMED06970389639921 EUDAMED06970389639938 EUDAMED
- Basic UDI-DI
- 697038963FDOCNM EUDAMED
- Direct Marketing DI
- 06970389630164 EUDAMED06970389630720 EUDAMED06970389639907 EUDAMED06970389639921 EUDAMED06970389639938 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
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
Oxygen Concentrator by Famidoc Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697038963FDOCNM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Famidoc Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016603
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED f608f102-2c18-4e8e-8236-dbc3b1150dc0 61 fields · synced Jul 27, 2026
- EUDAMED a410fdd8-7163-4412-a325-c91c620bdef6 61 fields · synced May 17, 2026
- EUDAMED 132df1dd-4f56-4565-bea9-515855c0e277 61 fields · synced May 18, 2026
- EUDAMED e4b3a6d1-597d-4fe5-b2bc-e7c496b446a3 61 fields · synced May 18, 2026
- EUDAMED 4a7d82a5-5cb0-4cdd-99c8-b87450c49469 61 fields · synced May 19, 2026