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SINA Comfort XXL
EUDAMEDClass I (EU MDR)
Ref K123 BEKA Duschliegen & Duschpulte und deren Zubehör
Identity
- Trade Name
- SINA Comfort XXL EUDAMED
- Device Name
- SINA Comfort HYD 160 EUDAMED
- Model / Reference
- K123 BEKA Duschliegen & Duschpulte und deren Zubehör EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260735021169 EUDAMED
- Basic UDI-DI
- 426068189123BT EUDAMED
- Direct Marketing DI
- 04260735021169 EUDAMED
- EMDN Code
- Y093312 SHOWER STRETCHERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Bathing/changing table, mobile
SINA Comfort XXL by BEKA Hospitec GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Bathing/changing table, mobile.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426068189123BT | Class I | Active |
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Manufacturer
- Manufacturer
- BEKA-Hospitec GmbH
- EUDAMED SRN
- DE-MF-000013895
Sources (1)
- EUDAMED 344f7201-80ca-45e2-88d4-9800c68ded75 61 fields · synced Jul 22, 2026