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EmpowerCTA+ Ceiling Column Medium
EUDAMEDFDA UDIClass I (EU MDR)
Ref 017414Model EmpowerCTA+®
Identity
- Trade Name
- EmpowerCTA+ Ceiling Column Medium EUDAMEDCeiling Column Medium FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Model / Reference
- EmpowerCTA+® EUDAMED017414 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 017414 FDA UDI
- Primary DI / UDI-DI
- 37630039300662 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300393100000JM EUDAMED
- FDA Product Code
- DSB FDA UDIJAK FDA UDIIZQ FDA UDI
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
- GMDN Term
- CT contrast medium injection system, line-powered, stationary FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2770 FDA UDI892.1750 FDA UDI870.1650 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EmpowerCTA+ Ceiling Column Medium by Bracco Injeneering SA — 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 | 76300393100000JM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bracco Injeneering SA
- EUDAMED SRN
- CH-MF-000019387
- Authorised Representative
- ACIST Europe BV NL-AR-000002151
Sources (2)
- EUDAMED 00e23bf7-1bbe-43c0-ba19-3315d8f31eee 61 fields · synced Jun 19, 2026
- FDA UDI caaf9952-75af-4ca4-8098-984dd46d728c 35 fields · synced May 30, 2026