Identity
- Device Name
- SENSORIAL-OCUPACIONAL EUDAMED
- Model / Reference
- EM.3425 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436602178373 EUDAMED
- Basic UDI-DI
- 843660217SSWT EUDAMED
- Direct Marketing DI
- 08436602178373 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Sensorial-Ocupacional by Ortotecsa, S.l. — Class I — 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 | 843660217SSWT | Class I | Active |
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Manufacturer
- Manufacturer
- Ortotecsa, S.l.
- EUDAMED SRN
- ES-MF-000004786
Sources (1)
- EUDAMED 4126cebb-9705-4d19-8128-fbc615725b36 61 fields · synced Jun 18, 2026