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CT 5000 change table, lying surface in compact laminate, 700 x 1200 mm , white.…
EUDAMEDFDA UDIClass I (EU MDR)
Ref R8455512000Model R84/R87
Identity
- Trade Name
- CT 5000 change table, lying surface in compact laminate, 700 x 1200 mm , white. With safety rail and body belt, foldable, fixed height, wall-mounted EUDAMEDCT 5000 FDA UDI
- Generic Name
- Bathing/changing table, stationary FDA UDI
- Device Name
- Change table Wall-m. F EUDAMEDCT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safety rail and body belt, foldable, fixed height, wall-mounted FDA UDI
- Model / Reference
- R84/R87 EUDAMEDR8455512000 EUDAMEDR8455512 FDA UDI
- Description
- CT 5000 change table, lying surface in compact laminate, 27.6 x 47.2'' , white. With safety rail and body belt, foldable, fixed height, wall-mounted FDA UDI
Identifiers
- Catalog Number
- R8455512000 FDA UDI
- Primary DI / UDI-DI
- 57085903765858 EUDAMED05708590376585 FDA UDI
- Basic UDI-DI
- 570859043600R84TB EUDAMED
- Direct Marketing DI
- 57085903765858 EUDAMED
- FDA Product Code
- INT FDA UDI
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER 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
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
Category: Hydrotherapy bath/tank
CT 5000 change table, lying surface in compact laminate, 700 x 1200 mm , white.… by Pressalit A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 d7aea4bd-e8b8-4797-84d6-481b5c2c4014 61 fields · synced Jun 19, 2026
- FDA UDI bc8fd76c-1397-42f8-865b-508514c0ab16 35 fields · synced May 29, 2026