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Shower seat, foldable, without legs
EUDAMEDFDA UDIClass I (EU MDR)
Ref 40-43016-2
by Ropox a/s
Identity
- Trade Name
- Shower seat, foldable, without legs EUDAMEDShower Seat FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Shower seat EUDAMED
- Model / Reference
- 40-43016-2 EUDAMEDFoldable, without leg FDA UDI
Identifiers
- Catalog Number
- 40-43016-2 FDA UDI
- Primary DI / UDI-DI
- 05707581000768 EUDAMEDFDA UDI
- Basic UDI-DI
- 57075810009RD EUDAMED
- Direct Marketing DI
- 05707581000768 EUDAMED
- FDA Product Code
- INN FDA UDI
- EMDN Code
- Y093303 FIXED AND ROTARY CHAIRS FOR BATH AND SHOWER EUDAMED
- GMDN Term
- Shower seat, non-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 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
Shower seat, foldable, without legs by Ropox A/S — 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 | 57075810009RD | 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 e1e5163f-9b43-44d4-9a5d-2dfcba6127e2 61 fields · synced Jul 9, 2026
- FDA UDI 79708841-2527-4d5f-8836-c4356430ac58 34 fields · synced May 29, 2026