Bracco Injeneering SA
CH-MF-000019387 · Switzerland · Lausanne
Bracco Injeneering SA is registered in the European database on medical devices as a manufacturer, with 19 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIb | 4 |
|---|---|
| Class IIa | 15 |
Most frequent device types declared: 017285, 640061, 640063, 640647, 650208.
Among these devices, 3 are declared sterile, 3 active.
Authorised representative in the Union: ACIST Europe BV.
Devices declared under this manufacturer
- CT Expres Evo
- CT Expres Floor Stand
- CT Expres Handle
- CT Expres Multi Patient Set
- CT Expres Patient Line
- CT Expres Patient Set Evo
- EmpowerCTA+ Ceiling Column (Long)
- EmpowerCTA+ Ceiling Column Medium
- EmpowerCTA+ Empower 220V Line Cord Kit Continental Europe
- EmpowerCTA+ Empower 220V Line Cord Kit, UK
- EmpowerCTA+ Floor Stand
- EmpowerCTA+ Injector System
Showing 12 of 19 declared devices.
Catalogue references include 017285, 017410, 017413, 017414, 017519, 017520.
European nomenclature codes declared: Z11039014.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | Bracco Injeneering S.A. (CH) · FDA 3004753774 |
| Devices in EUDAMED | 19 |
| Country of registration | Switzerland |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 17 |
|---|---|
| Found in the U.S. device database | 9 |
| Share | 52.9 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | BRACCO INJENEERING S.A. |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 7 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 7 |
| First licensed | 2002-05-01 |
Licence types: Device Group (3), System (3), Device Group Family (1).
Licensed under: FASTLOAD CT SYRINGE PACK, EMPOWER INJECTOR SYSTEMS, CT EXPRES 3D CONTRAST MEDIA DELIVERY SYSTEM, FASTLOAD CTA DUAL SYRINGE PACK, FASTLOAD MR SYRINGE PACK, EMPOWERMR INJECTOR SYSTEM.