Identity
- Trade Name
- Pediatric SACH FOOT 16L EUDAMED
- Device Name
- Prostheses EUDAMED
- Model / Reference
- 1105-16L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809689802552 EUDAMED
- Basic UDI-DI
- 880968980STNGPROS9QUS EUDAMED
- EMDN Code
- Y062403 FOOT PARTIAL PROSTHESES (INCLUDING TOE PROSTHESES) 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
Pediatric SACH FOOT 16L 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 |
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Manufacturer
- Manufacturer
- ST&G Corporation
- EUDAMED SRN
- KR-MF-000010453
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 06c204f0-9700-4cb2-94ee-a7903f2d87c3 61 fields · synced Jul 14, 2026