Identity
- Trade Name
- CoMoveIT Smart H3 EUDAMEDCoMoveIT FDA UDI
- Generic Name
- Wheelchair steering/control unit FDA UDI
- Device Name
- CoMoveIT Smart EUDAMEDAdaptive switched head array. FDA UDI
- Model / Reference
- CM0001 EUDAMEDSmart H3 FDA UDI
- Description
- Adaptive switched head array. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05430002911014 EUDAMEDFDA UDI
- Basic UDI-DI
- 5430002911CMSMART1DX EUDAMED
- Direct Marketing DI
- 05430002911014 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
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
CoMoveIT Smart H3 by Comoveit — 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 | 5430002911CMSMART1DX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CoMoveIT
- EUDAMED SRN
- BE-MF-000017867
Sources (2)
- EUDAMED f1d373c4-6764-4210-a6c0-20acdeb6eb13 61 fields · synced Jul 21, 2026
- FDA UDI 902dfe9b-0b57-4f31-9d78-b54b5042b5f6 34 fields · synced May 30, 2026