Identity
- Trade Name
- EmpowerCTA+ Injector System EUDAMEDFDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Device Name
- EmpowerCTA+ Injector System EUDAMEDComposed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector FDA UDI
- Model / Reference
- 017285 EUDAMED017285, 019775 FDA UDI
- Description
- Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 47630039302014 EUDAMEDFDA UDI
- Basic UDI-DI
- B-47630039302014 EUDAMED
- 510(k) Number
- K071378 FDA UDI
- FDA Product Code
- JAK FDA UDIDSB 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 IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI870.2770 FDA UDI870.1650 FDA UDI
- Market of Registration
- Poland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
EmpowerCTA+ Injector System by Bracco Injeneering SA — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-47630039302014 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 33fbf4a0-c7f9-4e50-b054-cfd06565e933 61 fields · synced May 30, 2026
- FDA UDI 1af6e219-44f2-4b0c-90b0-87e8c49ce884 34 fields · synced May 30, 2026