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CT Gantry Cover C307
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1271Model CT Gantry Cover
Identity
- Trade Name
- CT Gantry Cover C307 EUDAMEDpearltec FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- CT Gantry Cover EUDAMEDShort-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient’s skin. Non-Sterile and not to be used in the sterile field. FDA UDI
- Model / Reference
- CT Gantry Cover EUDAMED1271 EUDAMEDProFoam Head FDA UDI
- Description
- Short-term patient positioning and stabilization device during invasive and noninvasive procedures to be used on intact patient’s skin. Non-Sterile and not to be used in the sterile field. FDA UDI
Identifiers
- Catalog Number
- 1245 FDA UDI
- Primary DI / UDI-DI
- 07640178061484 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017806GantryCoverHT EUDAMED
- Direct Marketing DI
- 07640178061484 EUDAMED
- FDA Product Code
- KXH FDA UDI
- EMDN Code
- Z11030699 COMPUTED TOMOGRAPHS (CT) - OTHER EUDAMED
- GMDN Term
- Radiological general body-part positioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1830 FDA UDI
- Market of Registration
- Malta 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
Yes
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
MR Safe FDA UDI
CT Gantry Cover C307 by Pearl Technology Ag — 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 | 764017806GantryCoverHT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pearl Technology AG
- EUDAMED SRN
- CH-MF-000018100
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED e4486b90-f48b-4b4d-bdea-151a2ecea951 61 fields · synced Sep 18, 2026
- FDA UDI 54009702-6c57-4eca-a088-a4a0c601d9f7 35 fields · synced May 27, 2026