Identity
- Trade Name
- CS Prone Head Support System EUDAMEDFDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- Patient Positioner Accessories EUDAMED
- Model / Reference
- CSM 2560 EUDAMEDCSM2560 FDA UDI
Identifiers
- Catalog Number
- CSM2560 FDA UDI
- Primary DI / UDI-DI
- 05060624120114 EUDAMEDFDA UDI
- Basic UDI-DI
- 506062412FXFCU EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Patient positioner base plate FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Northern Ireland 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
No
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: Device sterilization/disinfection container, reusable
CS Prone Head Support System by Care Surgical Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 506062412FXFCU | 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 71afa75c-a7d6-41e8-b906-82d50f5a425d 61 fields · synced Jul 17, 2026
- FDA UDI 2ebbe449-cfbd-4ce0-b6fb-c70817a01137 33 fields · synced May 30, 2026