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Sign in to claim this brandBracco Injeneering S.A.
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Last updated May 23, 2026
What Bracco Injeneering S.A. makes
Bracco Injeneering S.A. manufactures transfer sets designed for medical imaging and diagnostic procedures, facilitating the safe and sterile movement of contrast agents or fluids between containers or equipment.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bracco Injeneering S.A. manufacture?
Bracco Injeneering S.A. specializes in manufacturing transfer sets, which are used in medical imaging and diagnostic procedures. These devices are designed to enable the safe and sterile transfer of contrast agents or fluids between containers or equipment, ensuring proper handling during procedures.
Where is Bracco Injeneering S.A. based, and how does that affect its regulatory standing?
Bracco Injeneering S.A. is headquartered in the United States, which means its devices are subject to FDA regulations. The company’s products are classified under Class II devices, indicating they pose moderate risk and require special controls to ensure safety and effectiveness.
Which regulatory registries or pathways list Bracco Injeneering S.A.’s devices?
Bracco Injeneering S.A.’s devices are listed through the FDA’s 510(k) pathway, a premarket submission process for Class II medical devices. This pathway demonstrates that the company’s transfer sets are substantially equivalent to legally marketed predicate devices, meeting FDA requirements for safety and performance.
How are Bracco Injeneering S.A.’s devices classified under FDA regulations?
Bracco Injeneering S.A.’s transfer sets fall under Class II classification by the FDA. This classification is based on the device’s intended use—facilitating sterile fluid transfer in medical imaging—and the associated risk level. Class II devices require additional controls beyond general controls but do not pose the highest risk (unlike Class III).
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (90)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Remote Control | 017380 | FDA UDI | Class II | Active |
| Floor Stand | 017410 | EUDAMEDFDA UDI | Class II | Active |
| Power/Comm Cable (60’ Plenum) | 017983 | FDA UDI | Class II | Active |
| Floor Stand | 016204 | FDA UDI | Class II | Active |
| Remote Control | 102409 | FDA UDI | Class II | Unknown |
| Floor Stand | 640076 | FDA UDI | Class II | Unknown |
| Extravasation Detection Patch with Access Slot | 017352 | FDA UDI | Class II | Active |
| Injector Mounting Arm, Right | 017418 | FDA UDI | Class II | Active |
| CT Exprès™ - Bottle Insulator | 640131 | FDA UDI | Class II | Active |
| Ceiling Mount Adapter Plate | 017419 | FDA UDI | Class II | Active |
| Injector head | 102410 | FDA UDI | Class II | Unknown |
| EmpowerCTA®+ Injector System with EDA | 017383 | FDA UDI | Class II | Unknown |
| FastLoad™ CTA Dual Syringe Pack | 017354 | FDA UDI | Class II | Active |
| EDA Clip | 015781 | FDA UDI | Class II | Active |
| FastLoad™ CT Syringe Pack | 017344 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System with EDA | 017383 | FDA UDI | Class II | Unknown |
| CT Exprès™ - Hand Switch | 640080 | FDA UDI | Class II | Active |
| Remote Control | 017380 | FDA UDI | Class II | Active |
| Pendant Cable | 017524 | FDA UDI | Class II | Active |
| EmpowerSync® Power Supply | 017353 | FDA UDI | Class II | Active |
| Injector Head | 102410 | FDA UDI | Class II | Active |
| CT Exprès™ - Bottle Spike Type A (30 mm) | 640458 | FDA UDI | Class II | Unknown |
| Injector Head | 102410 | FDA UDI | Class II | Active |
| Injector head | 017377 | FDA UDI | Class II | Unknown |
| Day Set III HP | 640460 | FDA UDI | Class II | Active |
| EmpowerCTA+ Injector System | 017285 | FDA UDI | Class II | Active |
| CT Exprès™ - Injector Unit | 651195 | FDA UDI | Class II | Active |
| Injector | 102410 | FDA UDI | Class II | Unknown |
| Power/Comm Cable (75') | 017412 | FDA UDI | Class II | Active |
| Transfer Set | 017349 | FDA UDI | Class II | Active |
| Philips Scanner Cable | 017613 | FDA UDI | Class II | Active |
| EmpowerSync® Power Supply | 017353 | FDA UDI | Class II | Active |
| EmpowerSync® Power Supply | 017353 | FDA UDI | Class II | Active |
| Accessory Kit | 017381 | FDA UDI | Class II | Active |
| EDA Module Kit | 017354 | FDA UDI | Class II | Active |
| Penetration Panel | 017382 | FDA UDI | Class II | Active |
| EmpowerSync® Power Supply | 017353 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System 1731 ed03 | 017285 | FDA UDI | Class II | Active |
| CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP, Patient Set | K151048 | FDA 510(k) | Class II | Active |
| Bracco Injeenering Transfer Set | K133147 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bracco Injeneering S.A. LAUSANNE Vaud · CH FEI 3004753774