Identity
- Trade Name
- CS Pro-Axis Compatible Set EUDAMEDFDA UDI
- Generic Name
- Operating table patient pressure distribution pad, single-use FDA UDI
- Device Name
- Operating Table Pads & Accessories (Disposables) EUDAMED
- Model / Reference
- CSM 4570 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- CSM 4570 FDA UDI
- Primary DI / UDI-DI
- 05060624121616 EUDAMEDFDA UDI
- Basic UDI-DI
- 506062412XXXGS EUDAMED
- Unit of Use DI
- 05060624120473 EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Operating table patient pressure distribution pad, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
CS Pro-Axis Compatible Set by Care Surgical Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 506062412XXXGS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Care Surgical Limited
- EUDAMED SRN
- GB-MF-000009074
- Authorised Representative
- Care Surgical Supplies Limited IE-AR-000001724
Sources (2)
- EUDAMED 01640795-d80d-4f6c-af1e-2e5e7be809ee 61 fields · synced Jun 19, 2026
- FDA UDI 23c7f51a-5493-4484-bc9a-c198f6c3e9aa 33 fields · synced May 30, 2026