Ingenjorsfirman Bjorn Bergdahl AB
SwedenFDA applicant, unverified
- Devices
- 1
What Ingenjorsfirman Bjorn Bergdahl AB makes
Ingenjorsfirman Bjorn Bergdahl AB manufactures the COA-COMP/M, an automated bipolar coagulator designed for precise tissue sealing in surgical procedures. This device is intended for use in medical settings where controlled coagulation is required, such as in minimally invasive surgeries.
The COA-COMP/M is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The manufacturer operates from the United States, adhering to regulatory standards applicable to its device portfolio.
Catalogue
Coa-Comp/M, Automated Bipolar Coagulator Ref K023733
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ingenjorsfirman Bjorn Bergdahl AB have in the registry?
The registry currently lists 1 device for Ingenjorsfirman Bjorn Bergdahl AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ingenjorsfirman Bjorn Bergdahl AB's devices?
Among its 1 most recently registered device, Ingenjorsfirman Bjorn Bergdahl AB has devices listed in FDA 510(k) (1 device).
What risk classes do Ingenjorsfirman Bjorn Bergdahl AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ingenjorsfirman Bjorn Bergdahl AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ingenjorsfirman Bjorn Bergdahl AB in the registry?
The most recently registered devices listed for Ingenjorsfirman Bjorn Bergdahl AB include COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR.