Identity
- Trade Name
- Sefam Access Pro EUDAMED
- Device Name
- Sefam Access Pro EUDAMED
- Model / Reference
- M-116800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700659491040 EUDAMED
- Basic UDI-DI
- 3700659416809R EUDAMED
- EMDN Code
- Z1203019082 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Sefam Access Pro 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 | 3700659416809R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sefam
- EUDAMED SRN
- FR-MF-000009061
Sources (1)
- EUDAMED 0c56d78b-ee20-4eab-8430-872731e65a0a 61 fields · synced Jul 13, 2026