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Speed Foot
EUDAMEDClass I (EU MDR)
Ref MD-SPF1Model Sport-specific Prosthetic Foot and Knee Systems
Identity
- Trade Name
- Speed Foot EUDAMED
- Model / Reference
- Sport-specific Prosthetic Foot and Knee Systems EUDAMEDMD-SPF1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867215636 EUDAMED
- Basic UDI-DI
- 697886721SP000TR EUDAMED
- Direct Marketing DI
- 06978867215636 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
Speed 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 | 697886721SP000TR | 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 2c156770-8d5f-4579-bc16-7aaa4dbabb13 61 fields · synced Jul 28, 2026