Identity
- Trade Name
- Artistep® S by Actimove® Cast Shoe EUDAMED
- Device Name
- Actimove® Cast Shoe Removable Toe Cover EUDAMED
- Model / Reference
- 65004-00007-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01230000153386 EUDAMED
- Basic UDI-DI
- 123000015365004PJ EUDAMED
- EMDN Code
- Y063303 READY-MADE ORTHOTIC SHOES 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
Artistep® S by Actimove® Cast Shoe by Span Link International Llc — 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 | 123000015365004PJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Span Link International, LLC
- EUDAMED SRN
- US-MF-000012261
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 21fb5c78-91e7-4ce4-9416-f2c52ea0fc04 61 fields · synced Jul 31, 2026