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Twister Basic, (300mm), Yellow
EUDAMEDFDA UDIClass I (EU MDR)
Ref P011-17
by mo-vis bv
Identity
- Trade Name
- Twister Basic, (300mm), Yellow EUDAMEDmo-Vis FDA UDI
- Generic Name
- Assistive input-control operation training device, selection techniques FDA UDI
- Device Name
- Twister EUDAMEDTwister Basic (300 mm) Yellow FDA UDI
- Model / Reference
- P011-17 EUDAMEDP005-17 FDA UDI
- Description
- Twister Basic (300 mm) Yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05407008320454 EUDAMEDFDA UDI
- Basic UDI-DI
- 540700832TWISTERSB EUDAMED
- FDA Product Code
- KNN FDA UDI
- EMDN Code
- Y122403 WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS EUDAMED
- GMDN Term
- Assistive input-control operation training device, selection techniques 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
Twister Basic, (300mm), Yellow 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 | 540700832TWISTERSB | 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 7d6356c3-435b-429c-b3ca-bef80c71fc3c 61 fields · synced Jun 18, 2026
- FDA UDI 1f16fe36-3929-4350-8fce-44cccc4b28b5 33 fields · synced May 30, 2026