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Swivel Foot
EUDAMEDClass I (EU MDR)
Ref MD-SF1Model Prosthetic Ankle and Foot Systems
Identity
- Trade Name
- Swivel Foot EUDAMED
- Model / Reference
- Prosthetic Ankle and Foot Systems EUDAMEDMD-SF1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867215605 EUDAMED
- Basic UDI-DI
- 697886721AF000KD EUDAMED
- Direct Marketing DI
- 06978867215605 EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - 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
Swivel Foot by Medi Global Assistive Device Co., Ltd. — 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 | 697886721AF000KD | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED db2bc3bb-ccf6-4ef1-a350-0e241dc834b1 61 fields · synced Jul 10, 2026