Shower-/Changing Bed, 210 cm, with Back Support, Electric
EUDAMEDFDA UDIClass I (EU MDR)
by Ropox a/s
Identity
- Trade Name
- Shower-/Changing Bed, 210 cm, with Back Support, Electric EUDAMEDShowerbed FDA UDI
- Generic Name
- Bathing/changing table, stationary FDA UDI
- Device Name
- Shower-/Changing Bed EUDAMED
- Model / Reference
- 40-25079-2 EUDAMEDWith back support, 210cm FDA UDI
Identifiers
- Catalog Number
- 40-25079-2 FDA UDI
- Primary DI / UDI-DI
- 05707581000485 EUDAMEDFDA UDI
- Basic UDI-DI
- 57075810011QY EUDAMED
- Direct Marketing DI
- 05707581000485 EUDAMED
- FDA Product Code
- INQ FDA UDI
- EMDN Code
- Y093312 SHOWER STRETCHERS EUDAMED
- GMDN Term
- Bathing/changing table, stationary FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3760 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Bathing/changing table, mobile
Shower-/Changing Bed, 210 cm, with Back Support, Electric by Ropox A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Bathing/changing table, mobile.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57075810011QY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ropox a/s
- EUDAMED SRN
- DK-MF-000020145
Sources (2)
- EUDAMED 666f1015-5014-4888-901e-804641708de4 61 fields · synced Jul 16, 2026
- FDA UDI 3e9071b5-04b3-420e-b067-51d95494ddf8 34 fields · synced May 30, 2026