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AdaptLine Washbasin Unit, Manual
EUDAMEDFDA UDIClass I (EU MDR)
Ref 40-42110-4
by Ropox a/s
Identity
- Trade Name
- AdaptLine Washbasin Unit, Manual EUDAMEDAdaptLine FDA UDI
- Generic Name
- Height-adjustable washbasin bracket, manual FDA UDI
- Device Name
- AdaptLine EUDAMED
- Model / Reference
- 40-42110-4 EUDAMEDManual, Unit FDA UDI
Identifiers
- Catalog Number
- 40-42110-4 FDA UDI
- Primary DI / UDI-DI
- 05707581002540 EUDAMED05707581000744 FDA UDI
- Basic UDI-DI
- 57075810006R7 EUDAMED
- Direct Marketing DI
- 05707581002540 EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Height-adjustable washbasin bracket, manual FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 FDA UDI
- Market of Registration
- Denmark 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
No
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
Yes
FDA UDI
Category: Hydrotherapy bath/tank
AdaptLine Washbasin Unit, Manual by Ropox A/S — 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 | 57075810006R7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ropox a/s
- EUDAMED SRN
- DK-MF-000020145
Sources (2)
- EUDAMED b49d76ac-f16a-49ab-965f-3726dff4c05e 61 fields · synced Jun 19, 2026
- FDA UDI b99f57d6-cfaf-43b8-ae4e-8405d7906595 34 fields · synced May 29, 2026