Identity
- Trade Name
- EVO Kit EUDAMED
- Device Name
- EVO EUDAMED
- Model / Reference
- EVO Kit EUDAMEDEVO-KIT13/16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446901533 EUDAMED
- Basic UDI-DI
- 506044690EVOG3 EUDAMED
- Direct Marketing DI
- 05060446901533 EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
EVO Kit by Smartbox Assistive Technology Limited — 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 | 506044690EVOG3 | Class I | Active |
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Manufacturer
- Manufacturer
- Smartbox Assistive Technology Limited
- EUDAMED SRN
- GB-MF-000008343
- Authorised Representative
- REHAVISTA GmbH DE-AR-000030297
Sources (1)
- EUDAMED 80592f43-5fcc-448d-a805-b0e77ebc8f15 61 fields · synced Jun 19, 2026