Identity
- Trade Name
- Comfort Step Footshell only, 23L EUDAMED
- Device Name
- Prostheses EUDAMED
- Model / Reference
- 1118-SH-23L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800319600524 EUDAMED
- Basic UDI-DI
- 880968980STNGPROS9QUS EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - 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
Comfort Step Footshell only, 23L by ST&G Corporation — 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 | 880968980STNGPROS9QUS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ST&G Corporation
- EUDAMED SRN
- KR-MF-000010453
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 65a639ac-feee-4624-a41c-ebae66acd523 61 fields · synced Jul 17, 2026