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SINA Comfort EL 160
EUDAMEDFDA UDIClass I (EU MDR)
Ref K123 BEKA Duschliegen & Duschpulte und deren Zubehör
Identity
- Trade Name
- SINA Comfort EL 160 EUDAMEDSina Shower Trolley FDA UDI
- Generic Name
- Bathing/changing table, mobile FDA UDI
- Device Name
- SINA Comfort HYD 160 EUDAMEDSina Shower Trolley FDA UDI
- Model / Reference
- K123 BEKA Duschliegen & Duschpulte und deren Zubehör EUDAMED930507408 FDA UDI
- Description
- Sina Shower Trolley FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260735021176 EUDAMEDFDA UDI
- Basic UDI-DI
- 426068189123BT EUDAMED
- Direct Marketing DI
- 04260735021176 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- Y093312 SHOWER STRETCHERS EUDAMED
- GMDN Term
- Bathing/changing table, mobile FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5510 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
SINA Comfort EL 160 by BEKA Hospitec 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 | 426068189123BT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BEKA-Hospitec GmbH
- EUDAMED SRN
- DE-MF-000013895
Sources (2)
- EUDAMED c92112e9-fe9b-4227-bcf7-75e2226dcbb3 61 fields · synced Jun 18, 2026
- FDA UDI 6bca125d-0c2f-4917-8399-4e4a5d63e0b6 33 fields · synced May 24, 2026