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e-motion DuoDrive
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1594425Model e-motion M25 DuoDrive
by Alber GmbH
Identity
- Trade Name
- e-motion DuoDrive EUDAMEDe-motion® FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- e-motion M25 DuoDrive EUDAMED
- Model / Reference
- e-motion M25 DuoDrive EUDAMED1594425 EUDAMEDM25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727211547 EUDAMEDFDA UDI
- Basic UDI-DI
- 4046727e-motionM25DuoDrFR EUDAMED
- 510(k) Number
- K192618 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
- Market of Registration
- Germany 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
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
e-motion DuoDrive 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 | 4046727e-motionM25DuoDrFR | 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 (2)
- EUDAMED 1cf6d0f3-c4f2-48cb-b9be-b8b168677c9b 61 fields · synced Jul 15, 2026
- FDA UDI 2252790e-01ab-4667-9df5-609ca014c5f7 33 fields · synced May 30, 2026