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scalacombi S36
EUDAMEDFDA UDIClass I (EU MDR)
Ref Y183012Model scalacombi S36Ref 1566813
by Alber GmbH
Identity
- Trade Name
- scalacombi S36 EUDAMEDscalamobil® FDA UDI
- Generic Name
- Stairclimber FDA UDI
- Device Name
- scalacombi S36 EUDAMED
- Model / Reference
- scalacombi S36 EUDAMEDY183012 EUDAMED1566813 EUDAMEDS35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04046727172114 EUDAMEDFDA UDI04046727172107 EUDAMED
- Basic UDI-DI
- 4046727scalacombiS366D 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
- 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
scalacombi S36 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 | 4046727scalacombiS366D | 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 b206a2b8-f4f9-4701-9cfc-8085c21ad924 61 fields · synced Jul 31, 2026
- EUDAMED 5c429834-06ab-40f4-be85-dd7939b79901 61 fields · synced May 18, 2026
- FDA UDI f610ee21-bab1-4faa-94ee-2971f52b80a8 33 fields · synced May 30, 2026