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VALUE IV folding shower seat, 440 mm, with support leg, anthracite. Fixed heigh…
EUDAMEDFDA UDIClass I (EU MDR)
Ref R1622000112Model R16
Identity
- Trade Name
- VALUE IV folding shower seat, 440 mm, with support leg, anthracite. Fixed height, wall-mounted EUDAMEDVALUE FDA UDI
- Generic Name
- Shower seat, non-powered FDA UDI
- Device Name
- Folding shower seat EUDAMEDVALUE IV folding shower seat, 17.3'', with support leg, anthracite. Fixed height, wall-mounted FDA UDI
- Model / Reference
- R16 EUDAMEDR1622000112 EUDAMEDR1622000 FDA UDI
- Description
- VALUE IV folding shower seat, 17.3'', with support leg, anthracite. Fixed height, wall-mounted FDA UDI
Identifiers
- Catalog Number
- R1622000112 FDA UDI
- Primary DI / UDI-DI
- 57085903777288 EUDAMED05708590377728 FDA UDI
- Basic UDI-DI
- 570859034936R16WA EUDAMED
- Direct Marketing DI
- 57085903777288 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VALUE IV folding shower seat, 440 mm, with support leg, anthracite. Fixed heigh… by Pressalit A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 570859034936R16WA | 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 8d4ef896-41e7-45de-9957-c69b71bee137 61 fields · synced Jul 9, 2026
- FDA UDI ccf1d95f-2613-477b-885f-4edbf89eace4 35 fields · synced May 30, 2026