Identity
- Trade Name
- Néa H2O EUDAMED
- Device Name
- Néa H2O EUDAMED
- Model / Reference
- M-217030-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700659400875 EUDAMED
- Basic UDI-DI
- 37006594170198 EUDAMED
- EMDN Code
- R060201 ACTIVE VENTILATION HUMIDIFICATION SYSTEMS, 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 H2O 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 | 37006594170198 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sefam
- EUDAMED SRN
- FR-MF-000009061
Sources (1)
- EUDAMED 6ced0d7d-8a38-45ba-9fd0-d7115d061928 61 fields · synced Jul 11, 2026