← Back to catalogue
ECU Mounting Plate Ottobock
EUDAMEDFDA UDIClass I (EU MDR)
Ref CM0001
by CoMoveIT
Identity
- Trade Name
- ECU Mounting Plate Ottobock EUDAMEDCoMoveIT FDA UDI
- Generic Name
- Wheelchair bracket/mount FDA UDI
- Device Name
- CoMoveIT Smart EUDAMEDECU mount CoMoveIT Smart for Ottobock powered wheelchairs. FDA UDI
- Model / Reference
- CM0001 EUDAMEDECU Mount For Ottobock FDA UDI
- Description
- ECU mount CoMoveIT Smart for Ottobock powered wheelchairs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05430002911076 EUDAMEDFDA UDI
- Basic UDI-DI
- 5430002911CMSMART1DX EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- Y122403 WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS EUDAMED
- GMDN Term
- Wheelchair bracket/mount 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ECU Mounting Plate Ottobock 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CoMoveIT
- EUDAMED SRN
- BE-MF-000017867
Sources (2)
- EUDAMED 4e8bf32c-14b0-4757-b9aa-4e1ceacacf2f 61 fields · synced Jun 19, 2026
- FDA UDI 660a6403-9d08-42dd-9808-ca5d9be39a67 34 fields · synced May 29, 2026