Bregas AB
SwedenFDA 510(k) applicant, unverified
- Devices
- 2
What Bregas AB makes
Bregas AB manufactures medical devices including the CO₂ Clip, a device used for sealing or occluding blood vessels or ducts during surgical procedures, and the C-IT system, designed for intraoperative imaging and guidance in minimally invasive surgeries.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, and the company is based in the United States.
Catalogue
Frequently asked questions
How many devices does Bregas AB have in the registry?
The registry currently lists 2 devices for Bregas AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bregas AB's devices?
Among its 2 most recently registered devices, Bregas AB has devices listed in FDA 510(k) (2 devices).
What risk classes do Bregas AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bregas AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bregas AB in the registry?
The most recently registered devices listed for Bregas AB include CO2 CLIP and C-IT.