Identity
- Trade Name
- Néa Duo ST EUDAMED
- Device Name
- Néa Duo EUDAMED
- Model / Reference
- M-117014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700659401179 EUDAMED
- Basic UDI-DI
- 3700659417029A EUDAMED
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Néa Duo ST by Sefam — 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 | 3700659417029A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sefam
- EUDAMED SRN
- FR-MF-000009061
Sources (1)
- EUDAMED 3d7ff34f-5186-4a53-bce5-d7abcc6493bb 61 fields · synced Jul 12, 2026