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scalamobil
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1595225Model scalamobil S45Ref 1521111Model scalamobil S38
by Alber GmbH
Identity
- Trade Name
- scalamobil EUDAMEDscalamobil S38 EUDAMEDscalamobil® FDA UDI
- Generic Name
- Stairclimber FDA UDI
- Device Name
- scalamobil S45 EUDAMEDscalamobil S38 EUDAMED
- Model / Reference
- scalamobil S45 EUDAMED1595225 EUDAMEDscalamobil S38 EUDAMED1521111 EUDAMEDS35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727236670 EUDAMED04046727151652 EUDAMEDFDA UDI
- Basic UDI-DI
- 4046727scalamobilS45AX EUDAMED4046727scalamobilS38B2 EUDAMED
- 510(k) Number
- K920105 FDA UDI
- FDA Product Code
- ING FDA UDI
- EMDN Code
- Y183012 MOBILE STAIRLIFTS EUDAMED
- GMDN Term
- Stairclimber FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3930 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
scalamobil 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 | 4046727scalamobilS45AX | 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 cd75c732-8f7c-4ea7-ba5b-03cf96a71846 61 fields · synced Jul 29, 2026
- EUDAMED 43f1948a-fe51-4d8b-bf9d-b99d2cd1ac9b 61 fields · synced May 18, 2026
- FDA UDI e6e9efa0-18ed-47aa-8d47-9c646338c476 33 fields · synced May 30, 2026