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James
EUDAMEDFDA UDIClass I (EU MDR)
Ref K121 BEKA Duschstühle und deren ZubehöreModel K121 BEKA Dusch- und Badelifter und deren Zubehöre
Identity
- Trade Name
- JAMES EUDAMEDJAMES 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 EUDAMED920125000 FDA UDI
- Description
- Multifunctional shower chair FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260681890208 EUDAMED04260681890420 EUDAMED04260681890192 EUDAMEDFDA UDI
- Basic UDI-DI
- 426068189121BP EUDAMED
- Direct Marketing DI
- 04260681890208 EUDAMED04260681890420 EUDAMED04260681890192 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
James 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 e2fae5a2-9bae-4b98-af8b-c77a591a2950 61 fields · synced Jul 29, 2026
- EUDAMED e20926d1-3f38-4986-b938-85a7a3853fa6 61 fields · synced May 17, 2026
- EUDAMED 00ff770d-9521-4264-8d3f-011b3eb321e5 61 fields · synced May 19, 2026
- FDA UDI 02180de0-74c1-474e-9468-9c9913f45006 33 fields · synced May 25, 2026