Identity
- Trade Name
- Face Guard Mirror EUDAMEDFDA UDI
- Generic Name
- Patient positioner base plate FDA UDI
- Device Name
- Patient Positioner Accessories EUDAMEDMirror for use in the prone position. The cogs fitted to the mirror adjust the height or angle of the Face Guard Helmet to achieve the safest natural neutral neckline. FDA UDI
- Model / Reference
- 925.FGM EUDAMEDFDA UDI
- Description
- Mirror for use in the prone position. The cogs fitted to the mirror adjust the height or angle of the Face Guard Helmet to achieve the safest natural neutral neckline. FDA UDI
Identifiers
- Catalog Number
- 925.FGM FDA UDI
- Primary DI / UDI-DI
- 05060624125638 EUDAMEDFDA UDI
- Basic UDI-DI
- 506062412FXFCU EUDAMED
- Direct Marketing DI
- 05060624125638 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
Face Guard Mirror 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 1c8ff521-c04a-49bb-9a81-54db7513ffcb 61 fields · synced Jun 20, 2026
- FDA UDI 047a0a80-cd15-493b-9c86-581de8426dad 34 fields · synced May 30, 2026