Identity
- Trade Name
- VGK-S EUDAMED
- Device Name
- VGK-S EUDAMED
- Model / Reference
- VGK100S EUDAMEDVGK100C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060777980061 EUDAMED
- Basic UDI-DI
- 506077798VGKPROXIMAL6F 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
Vgk-S by Orthomobility Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Mechatronic external knee prosthesis.
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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 | 506077798VGKPROXIMAL6F | Class I | Active |
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Manufacturer
- Manufacturer
- Orthomobility Ltd.
- EUDAMED SRN
- GB-MF-000028506
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 2eb6b2cf-4c95-44d3-80b6-d69b6d09374e 61 fields · synced Jun 11, 2026