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Foot Control Omni
EUDAMEDFDA UDIClass I (EU MDR)
Ref P021-51Model P021
by mo-vis bv
Identity
- Trade Name
- Foot Control Omni EUDAMEDmo-Vis FDA UDI
- Generic Name
- Assistive rotating/sliding positioning system FDA UDI
- Device Name
- Foot Control EUDAMEDFoot Control Omni FDA UDI
- Model / Reference
- P021 EUDAMEDP021-51 EUDAMEDFDA UDI
- Description
- Foot Control Omni FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05407008321024 EUDAMEDFDA UDI
- Basic UDI-DI
- 540700832FOOTCONTROL35 EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- Y122403 WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS EUDAMED
- GMDN Term
- Assistive rotating/sliding positioning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3920 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Foot Control Omni by mo-vis bv — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 540700832FOOTCONTROL35 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- mo-vis bv
- EUDAMED SRN
- BE-MF-000000729
Sources (2)
- EUDAMED 5dfe31e4-0e54-4aff-9452-bf6bee1d4974 61 fields · synced Jun 18, 2026
- FDA UDI b62e7f83-8663-4762-9354-2d343bba1a60 33 fields · synced May 30, 2026