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Eve!
EUDAMEDFDA UDIClass I (EU MDR)
Ref K121 BEKA Dusch- und Badelifter und deren Zubehöre
Identity
- Trade Name
- EVE! EUDAMEDEVE! Bathing Lift FDA UDI
- Generic Name
- Mobile patient lifting system, electrically-powered FDA UDI
- Device Name
- EVE! EUDAMEDEVE! Bathing Lift FDA UDI
- Model / Reference
- K121 BEKA Dusch- und Badelifter und deren Zubehöre EUDAMED920108000 FDA UDI
- Description
- EVE! Bathing Lift FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260735020025 EUDAMEDFDA UDI
- Basic UDI-DI
- 426068189121BP EUDAMED
- Direct Marketing DI
- 04260735020025 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- V08050303 BATH LIFTS EUDAMED
- GMDN Term
- Mobile patient lifting system, electrically-powered 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
Eve! 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 | 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 (2)
- EUDAMED 10e84f25-f374-4f86-8a36-f3770a6ecad3 61 fields · synced Jul 22, 2026
- FDA UDI 781bcfb3-bb53-4315-9d96-cec9c5e994ef 33 fields · synced May 25, 2026