Identity
- Trade Name
- Headset Mounting Clamp EUDAMEDCoMoveIT FDA UDI
- Generic Name
- Wheelchair bracket/mount FDA UDI
- Device Name
- CoMoveIT Smart EUDAMEDMounting clamp for CoMoveIT Smart H3. FDA UDI
- Model / Reference
- CM0001 EUDAMEDHeadset Mounting Clamp FDA UDI
- Description
- Mounting clamp for CoMoveIT Smart H3. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05430002911069 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
Headset Mounting Clamp 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 c51aa542-e8fd-4bd6-bab4-61724097fede 61 fields · synced Aug 2, 2026
- FDA UDI af943b5e-16a9-4915-8be1-584950e5583b 34 fields · synced May 30, 2026