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Brisk Double-Sole Carbon Fiber Foot
EUDAMEDClass I (EU MDR)
Ref BF-10HModel Prosthetic Ankle and Foot Systems
Identity
- Trade Name
- Brisk Double-Sole Carbon Fiber Foot EUDAMED
- Model / Reference
- Prosthetic Ankle and Foot Systems EUDAMEDBF-10H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979221074678 EUDAMED
- Basic UDI-DI
- 697886721AF000KD EUDAMED
- Direct Marketing DI
- 06979221074678 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
Brisk Double-Sole Carbon Fiber 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 16dea9dd-dfd7-412a-8bd1-ec7ab736aca9 61 fields · synced Jun 18, 2026