Identity
- Trade Name
- S.Box EUDAMED
- Model / Reference
- S.Box EUDAMEDM-116412 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03700659400868 EUDAMED
- Basic UDI-DI
- 3700659416409D EUDAMED
- Direct Marketing DI
- 03700659400868 EUDAMED
- EMDN Code
- Z12030102 CONTINUOUS POSITIVE PRESSURE EQUIPMENT 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
S.Box 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 | 3700659416409D | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sefam
- EUDAMED SRN
- FR-MF-000009061
Sources (1)
- EUDAMED cd6ee313-3982-4776-8cb9-392513cb1438 61 fields · synced Jun 18, 2026