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Leon
EUDAMEDFDA UDIClass I (EU MDR)
Ref K121 BEKA Duschstühle und deren ZubehöreModel K121 BEKA Dusch- und Badelifter und deren Zubehöre
Identity
- Trade Name
- LEON EUDAMEDLEON Multifunctional shower chair FDA UDI
- Generic Name
- Shower seat, power-adjusted FDA UDI
- Device Name
- EVE! EUDAMEDMultifunctional shower chair FDA UDI
- Model / Reference
- K121 BEKA Dusch- und Badelifter und deren Zubehöre EUDAMEDK121 BEKA Duschstühle und deren Zubehöre EUDAMED920124500 FDA UDI
- Description
- Multifunctional shower chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260681890444 EUDAMED04260681890260 EUDAMED04260681890253 EUDAMEDFDA UDI
- Basic UDI-DI
- 426068189121BP EUDAMED
- Direct Marketing DI
- 04260681890444 EUDAMED04260681890260 EUDAMED04260681890253 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Shower seat, power-adjusted 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
Category: Hydrotherapy bath/tank
Leon by BEKA Hospitec GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 426068189121BP | 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 (4)
- EUDAMED b65c478e-585e-48ef-a148-476e248185f7 61 fields · synced Aug 4, 2026
- EUDAMED 2dccf7c2-e048-4dec-8682-570f52225467 61 fields · synced May 17, 2026
- EUDAMED f2b9d2cc-f3ec-49d3-9ce4-c3828ef5ed79 61 fields · synced May 18, 2026
- FDA UDI 709c13c5-0d46-4a0c-96c3-cbda9d36b19c 33 fields · synced May 30, 2026