← Back to catalogue
twion
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 1592491Model twion T24 (M24)510(k) K151717
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) EUDAMED1592491 EUDAMEDT24 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727184186 EUDAMEDFDA UDI
- 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 — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151717 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 4046727twionTE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alber GmbH
- EUDAMED SRN
- DE-MF-000005502
Sources (3)
- EUDAMED f59c15e0-4bd6-4456-a1a6-9991db0dd4ba 85 fields · synced Jun 18, 2026
- FDA UDI 6fec0495-fccd-4fde-b46a-680a51188b70 33 fields · synced May 30, 2026
- FDA 510(k) K151717 1 fields · synced May 18, 2026