SCT 1000 shower change table, lying surface 600 x 1800 mm, with safety rail, fo…
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- SCT 1000 shower change table, lying surface 600 x 1800 mm, with safety rail, foldable, white. Fixed height, wall-mounted EUDAMEDShowering and changing table 1000 FDA UDI
- Generic Name
- Bathing/changing table, stationary FDA UDI
- Device Name
- Change table Wall-m. F EUDAMEDShowering and changing table 1000, fixed height, 1800 mm, with safety rail, white FDA UDI
- Model / Reference
- R84/R87 EUDAMEDR8407000 EUDAMEDR8407 FDA UDI
- Description
- Showering and changing table 1000, fixed height, 1800 mm, with safety rail, white FDA UDI
Identifiers
- Catalog Number
- R8407000 FDA UDI
- Primary DI / UDI-DI
- 57085902948276 EUDAMED05708590294827 FDA UDI
- Basic UDI-DI
- 570859043600R84TB EUDAMED
- Direct Marketing DI
- 57085902948276 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 1000 shower change table, lying surface 600 x 1800 mm, with safety rail, fo… by Pressalit A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Bathing/changing table, mobile.
- SH TROLLEY TR4200, A JUNIOR, REMOVABLE BATT — Tr Equipment AB · Class II
- Easi-Lift Shower ¬Stretcher with headrest - Size 6 — SMIRTHWAITE LTD · Class I
- Shado® 240 PVC tray Adult – Rgo model — SCALEO MEDICAL · Class I
- Mobi Changer Size 2 - Mild Steel — SMIRTHWAITE LTD · Class I
- Easi-Lift Shower Stretcher without headrest - Size 4 — SMIRTHWAITE LTD · Class I
- Mobi Changer Size 3 - Mild Steel — SMIRTHWAITE LTD · Class I
- Shower-/Changing Bed, 210 cm, with Back Support, Electric — Ropox A/S · Class I
- SHOWER TROLLEY - hydraulic — TIMO d.o.o. Ajdovščina · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pressalit A/S
- EUDAMED SRN
- DK-MF-000001767
Sources (2)
- EUDAMED a53d542a-2a38-4bcc-9548-16b64c6688d0 61 fields · synced Jul 10, 2026
- FDA UDI a50e3f8c-2b94-408e-b228-4fefbaae72ef 35 fields · synced May 29, 2026