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StandardLine Washbasin Unit, Manual, Right
EUDAMEDFDA UDIClass I (EU MDR)
Ref 40-14760-1
by Ropox a/s
Identity
- Trade Name
- StandardLine Washbasin Unit, Manual, Right EUDAMEDStandardLine FDA UDI
- Generic Name
- Height-adjustable washbasin bracket, electric FDA UDI
- Device Name
- StandardLine Manual EUDAMED
- Model / Reference
- 40-14760-1 EUDAMEDManual, Right, Unit FDA UDI
Identifiers
- Catalog Number
- 40-14760-1 FDA UDI
- Primary DI / UDI-DI
- 05707581015120 EUDAMEDFDA UDI
- Basic UDI-DI
- 57075810017RC EUDAMED
- Direct Marketing DI
- 05707581015120 EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
- GMDN Term
- Height-adjustable washbasin bracket, electric 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
StandardLine Washbasin Unit, Manual, Right 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 | 57075810017RC | 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 0c343cb7-4371-49c4-b4bf-8403bba126b5 61 fields · synced Jul 22, 2026
- FDA UDI 92196225-25b7-4cbd-ac9e-31cab37f4c1b 34 fields · synced May 30, 2026