PLUS shower seat 450, with aperture, incl. backrest and armrests, white. Manual…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- PLUS shower seat 450, with aperture, incl. backrest and armrests, white. Manually height and sideways adjustable, for fitting to horizontal wall track EUDAMEDPLUS FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Shower seat 450 M EUDAMEDPLUS shower seat 450, with aperture, incl. backrest and armrests, white. Manually height and sideways adjustable, for fitting to horizontal wall track FDA UDI
- Model / Reference
- R74 EUDAMEDR7465000 EUDAMEDR7465 FDA UDI
- Description
- PLUS shower seat 450, with aperture, incl. backrest and armrests, white. Manually height and sideways adjustable, for fitting to horizontal wall track FDA UDI
Identifiers
- Catalog Number
- R7465000 FDA UDI
- Primary DI / UDI-DI
- 57085903600654 EUDAMED05708590360065 FDA UDI
- Basic UDI-DI
- 570859034936R74WQ EUDAMED
- Direct Marketing DI
- 57085903600654 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
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
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
This medical device, the PLUS shower seat 450, with aperture, incl. backrest and armrests, white, manually height and sideways adjustable for fitting to horizontal wall track, is designed for patients who require a safe and convenient way to bathe. Its unique features make it an ideal solution for patients with mobility or dexterity impairments.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 570859034936R74WQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pressalit A/S
- EUDAMED SRN
- DK-MF-000001767
Sources (2)
- EUDAMED 59d911a4-7ff1-415b-b4f5-067300fabdd8 61 fields · synced Aug 2, 2026
- FDA UDI cfc5ae8e-792d-4463-a359-85081d6c1624 35 fields · synced May 27, 2026