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SCT 2100 shower change table, coated canvas, fixed height, 1800 mm, with safety…
EUDAMEDFDA UDIClass I (EU MDR)
Ref R8425418000Model R84/R87
Identity
- Trade Name
- SCT 2100 shower change table, coated canvas, fixed height, 1800 mm, with safety rail and water collection tray, white EUDAMEDSCT 2100 FDA UDI
- Generic Name
- Bathing/changing table, stationary FDA UDI
- Device Name
- Change table Wall-m. F EUDAMEDSCT 2100 shower change table, coated canvas, 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 EUDAMEDR8425418000 EUDAMEDR8425418 FDA UDI
- Description
- SCT 2100 shower change table, coated canvas, lying surface 21.7'' x 65'', with safety rail and water collection tray, foldable, white. Fixed height, wall-mounted FDA UDI
Identifiers
- Catalog Number
- R8425418000 FDA UDI
- Primary DI / UDI-DI
- 57085903721748 EUDAMED05708590372174 FDA UDI
- Basic UDI-DI
- 570859043600R84TB EUDAMED
- Direct Marketing DI
- 57085903721748 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SCT 2100 shower change table, coated canvas, fixed height, 1800 mm, with safety… 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 | 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 a0324428-9866-4397-be8a-770e7b5dbe29 61 fields · synced Jun 18, 2026
- FDA UDI 97c9576c-cabd-4e34-8d70-ef94619b8331 35 fields · synced May 30, 2026