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Mona El 200-80
EUDAMEDFDA UDIClass I (EU MDR)
Ref K126 BEKA ANA & MONA Pflege-&VersorgungsliegenModel K126 BEKA Pflege- und Versorgungsliegen und deren Zubehör
Identity
- Trade Name
- MONA EL 200-80 EUDAMEDMona Mobile nursing- and care table FDA UDI
- Generic Name
- Bathing/changing table, mobile FDA UDI
- Device Name
- ANA EL 100-80 EUDAMEDMona Mobile nursing- and care table FDA UDI
- Model / Reference
- K126 BEKA Pflege- und Versorgungsliegen und deren Zubehör EUDAMEDK126 BEKA ANA & MONA Pflege-&Versorgungsliegen EUDAMED950104000 FDA UDI
- Description
- Mona Mobile nursing- and care table FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260735021268 EUDAMEDFDA UDI
- Basic UDI-DI
- 426068189126BZ EUDAMED
- Direct Marketing DI
- 04260735021268 EUDAMED
- FDA Product Code
- FSA FDA UDI
- EMDN Code
- Y1803 ASSISTIVE TABLES 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
Mona El 200-80 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 | 426068189126BZ | 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 80292b6c-5341-42df-b8d3-0e0e38da785b 61 fields · synced Jul 27, 2026
- FDA UDI a7bed2c6-0c3c-483b-880f-45bad3db2ac5 33 fields · synced May 29, 2026