Identity
- Device Name
- All-Terrain Knee EUDAMED
- Model / Reference
- ATK-PA-01 EUDAMEDATK-SF-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850038961022 EUDAMED
- Basic UDI-DI
- 0850038961ATK4K EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) 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
Category: Mechatronic external knee prosthesis
All-Terrain Knee by LegWorks, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0850038961ATK4K | Class I | Active |
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Manufacturer
- Manufacturer
- LegWorks, Inc.
- EUDAMED SRN
- US-MF-000018389
- Authorised Representative
- QNET B.V. NL-AR-000002695
Sources (1)
- EUDAMED 3105702f-90f8-417b-abbe-0b56ece60506 61 fields · synced Jul 19, 2026