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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
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- US
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Catalogue (90)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Patient Set | 640457 | FDA UDI | Class II | Active |
| Day Set III HP | 640460 | FDA UDI | Class II | Active |
| FastLoad™ MR Syringe Pack | 017348 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System | 017285 | FDA UDI | Class II | Unknown |
| EmpowerSync® Remote Control Pendant Switch | 017526 | FDA UDI | Class II | Active |
| Patient Set | 640457 | FDA UDI | Class II | Active |
| Injector | 102410 | FDA UDI | Class II | Active |
| Remote Control | 102409 | FDA UDI | Class II | Unknown |
| Floor Stand Shroud | 017411 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System | 017285 | FDA UDI | Class II | Active |
| Empower MR Injector Head | 017377 | FDA UDI | Class II | Active |
| Injector Mounting Arm, Left | 017417 | FDA UDI | Class II | Active |
| Remote Control (Onyx) | 102409 | FDA UDI | Class II | Unknown |
| Interconnect Power/Comm Cable (20') | 017421 | FDA UDI | Class II | Active |
| Ceiling Column Long | 017413 | EUDAMEDFDA UDI | Class II | Active |
| Remote Control | 102409 | FDA UDI | Class II | Active |
| Hydraulic Controller | 017378 | FDA UDI | Class II | Unknown |
| EmpowerMR® Injector System without Remote Control | 017377 | FDA UDI | Class II | Active |
| CT Expres™ 3D | 651207 | FDA UDI | Class II | Active |
| FastLoad™ MR Syringe Pack | 017356 | FDA UDI | Class II | Active |
| remote control 1731 ed 03 | 102409 | FDA UDI | Class II | Active |
| Power/Comm Cable (60’) | 017422 | FDA UDI | Class II | Active |
| Injector | 102410 | FDA UDI | Class II | Unknown |
| Remote Control | 017380 | FDA UDI | Class II | Unknown |
| Injector Mounting Arm, Left | 017417 | FDA UDI | Class II | Active |
| Ceiling Column Short | 017415 | FDA UDI | Class II | Active |
| EDA Module Kit | 017354 | FDA UDI | Class II | Unknown |
| Injector Head | 102410 | FDA UDI | Class II | Unknown |
| Power Supply to remote USB cable | 017527 | FDA UDI | Class II | Active |
| FastLoad™ CT Syringe Pack with spike | 017345 | FDA UDI | Class II | Active |
| CT Exprès™ - Control Panel | 650197 | FDA UDI | Class II | Active |
| Bottle Spike Type A | 640458 | FDA UDI | Class II | Active |
| CT Exprès™ - Day Set III HP | 640460 | FDA UDI | Class II | Active |
| Remote Control | 102409 | FDA UDI | Class II | Active |
| CT Exprès™ - Patient Set | 640457 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System | 017285 | FDA UDI | Class II | Unknown |
| Electro-Hydraulic Interconnect | 017379 | FDA UDI | Class II | Active |
| EmpowerSync® Philips Scanner Interface Adapter | 017523 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System | 017285 | FDA UDI | Class II | Unknown |
| EmpowerMR® Injector System without Remote Control | 017377 | FDA UDI | Class II | Active |
| EmpowerCTA®+ Injector System | 017285 | FDA UDI | Class II | Active |
| FastLoad™ CTA Dual Syringe Pack with spikes | 017347 | FDA UDI | Class II | Active |
| Injector Mounting Arm, Right | 017418 | FDA UDI | Class II | Active |
| FastLoad™ MR Syringe Pack | 017348 | FDA UDI | Class II | Active |
| FastLoad™ CTA Dual Syringe Pack | 017346 | FDA UDI | Class II | Active |
| IV pole | 017528 | FDA UDI | Class II | Active |
| FastLoad™ CTA Dual Syringe Pack with Spikes | 017355 | FDA UDI | Class II | Active |
| EDA Clip | 015781 | FDA UDI | Class II | Active |
| EmpowerSync® Cables | 017355 | FDA UDI | Class II | Active |
| Hydraulic Controller | 017378 | FDA UDI | 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