SCT 2000 shower change table, mesh cover, fixed height, 1800 mm, with safety ra…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- SCT 2000 shower change table, mesh cover, fixed height, 1800 mm, with safety rail and water collection tray, white EUDAMEDSCT 2000 FDA UDI
- Generic Name
- Bathing/changing table, stationary FDA UDI
- Device Name
- Change table Wall-m. F EUDAMEDSCT 2000 shower change table, mesh cover, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, wall-mounted FDA UDI
- Model / Reference
- R84/R87 EUDAMEDR8425218000 EUDAMEDR8425218 FDA UDI
- Description
- SCT 2000 shower change table, mesh cover, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, wall-mounted FDA UDI
Identifiers
- Catalog Number
- R8425218000 FDA UDI
- Primary DI / UDI-DI
- 57085903721670 EUDAMED05708590372167 FDA UDI
- Basic UDI-DI
- 570859043600R84TB EUDAMED
- Direct Marketing DI
- 57085903721670 EUDAMED
- FDA Product Code
- INT FDA UDI
- EMDN Code
- Y093312 SHOWER STRETCHERS EUDAMED
- GMDN Term
- Bathing/changing table, stationary FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3520 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
Category: Bathing/changing table, mobile
SCT 2000 shower change table, mesh cover, fixed height, 1800 mm, with safety ra… by Pressalit A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 570859043600R84TB | 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 025daf37-55ce-4fa0-8135-d4ee5fd3f131 61 fields · synced Jun 19, 2026
- FDA UDI 79313a43-70cd-4c99-8eae-4eedd70eab66 35 fields · synced May 30, 2026