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Head Control Omni Switched
EUDAMEDFDA UDIClass I (EU MDR)
Ref P011-62Model P011
by mo-vis bv
Identity
- Trade Name
- Head Control Omni Switched EUDAMEDmo-vis FDA UDI
- Generic Name
- Wheelchair steering/control unit FDA UDI
- Device Name
- Head Control EUDAMEDSwitched Head Control FDA UDI
- Model / Reference
- P011 EUDAMEDP011-62 EUDAMEDP011-62 Head Control Omni Switched FDA UDI
- Description
- Switched Head Control FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05407008321109 EUDAMEDFDA UDI
- Basic UDI-DI
- 540700832HEADCONTROL8C EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- Y122403 WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS EUDAMED
- GMDN Term
- Wheelchair steering/control unit 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
No
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
Yes
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
Head Control Omni Switched 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 | 540700832HEADCONTROL8C | 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 c36783b6-ae70-470c-a18d-b48099c8310f 61 fields · synced Jun 19, 2026
- FDA UDI 3c24f5c3-0c54-4113-a568-f9d67a6d6530 33 fields · synced May 30, 2026