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twion
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1566460Model twion T24 (M24)Ref 1565810
by Alber GmbH
Identity
- Trade Name
- twion EUDAMEDtwion® FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- twion T24 (M24) EUDAMED
- Model / Reference
- twion T24 (M24) EUDAMED1566460 EUDAMED1565810 EUDAMEDT24 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727169107 EUDAMEDFDA UDI04046727162931 EUDAMED
- Basic UDI-DI
- 4046727twionTE EUDAMED
- 510(k) Number
- K151717 FDA UDI
- FDA Product Code
- ITI FDA UDI
- EMDN Code
- Y122410 ELECTRIC PROPULSION UNIT EUDAMED
- GMDN Term
- Wheelchair electric-motor-driven propulsion system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
twion by Alber GmbH — 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 | 4046727twionTE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Alber GmbH
- EUDAMED SRN
- DE-MF-000005502
Sources (3)
- EUDAMED daf71b2d-aadd-4f11-84d5-ce8cfa1fb859 61 fields · synced Jun 20, 2026
- EUDAMED c1835cb7-752e-42b6-a88f-96d8e48d944d 61 fields · synced May 18, 2026
- FDA UDI a4a58c49-7779-4a5c-8552-b0d81a2e2d1b 33 fields · synced May 30, 2026