Identity
- Trade Name
- smoov EUDAMEDSMOOV® FDA UDI
- Generic Name
- Wheelchair electric-motor-driven propulsion system FDA UDI
- Device Name
- SMOOV O10 EUDAMED
- Model / Reference
- SMOOV O10 EUDAMED1592898 EUDAMEDO10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727188252 EUDAMEDFDA UDI
- Basic UDI-DI
- 4046727SMOOVO10DX EUDAMED
- 510(k) Number
- K192016 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
smoov 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 | 4046727SMOOVO10DX | 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 a31f46a0-360a-47ee-a91f-638bc86d718a 61 fields · synced Jul 9, 2026
- FDA UDI b5529cf4-15ef-4866-8f0d-4ccb12c51c66 33 fields · synced May 30, 2026