Identity
- Trade Name
- Table, Surgical C-Arm, 230 VAC EUDAMEDSurgical C-Arm Table, Contour, 230V FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- Surgical C-Arm Tables EUDAMEDThe Surgical C-Arm Tables consists of a cantilevered low attenuation carbon fiber contour tabletop, designed to accommodate portable or ceiling-suspended C-Arm fluoroscopy systems. This model includes a 75" radiolucent area, free-float X-Y tabletop, motorized control of height, Isocentric lateral roll, Trendelenburg motions. FDA UDI
- Model / Reference
- 058-845 EUDAMEDFDA UDI
- Description
- The Surgical C-Arm Tables consists of a cantilevered low attenuation carbon fiber contour tabletop, designed to accommodate portable or ceiling-suspended C-Arm fluoroscopy systems. This model includes a 75" radiolucent area, free-float X-Y tabletop, motorized control of height, Isocentric lateral roll, Trendelenburg motions. FDA UDI
Identifiers
- Catalog Number
- 058-845 FDA UDI
- Primary DI / UDI-DI
- 00879942070521 EUDAMEDFDA UDI
- Basic UDI-DI
- 085994200610756 EUDAMED
- Direct Marketing DI
- 00879942070521 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
- GMDN Term
- Fluoroscopy/angiography table, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Table, Surgical C-Arm, 230 VAC by Mirion Technologies (Capintec), Inc. — 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 | 085994200610756 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED c392fa6a-f68d-473c-a310-4196debeddaa 61 fields · synced Jul 15, 2026
- FDA UDI d8af0657-bc63-45f3-9490-630d538e79b6 35 fields · synced May 26, 2026