Compex, Spol, S.R.O.
CzechiaFDA applicant, unverified
- Devices
- 4
What Compex, Spol, S.R.O. makes
Compex produces medical devices for tissue ablation, including the JETT Medical II and JETT PLASMA Medical II systems. These devices use plasma jet technology to target and remove tissue, primarily used in dermatological and surgical procedures.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. Compex is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
JETT Medical II Ref K240311
Regimes: 510(k) Registry: 510(k)JETT PLASMA Medical II Ref K213247
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 495080822
Frequently asked questions
How many devices does Compex, Spol, S.R.O. have in the registry?
The registry currently lists 4 devices for Compex, Spol, S.R.O.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Compex, Spol, S.R.O.'s devices?
Among its 4 most recently registered devices, Compex, Spol, S.R.O. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Compex, Spol, S.R.O.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Compex, Spol, S.R.O.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Compex, Spol, S.R.O. in the registry?
The most recently registered devices listed for Compex, Spol, S.R.O. include JETT PLASMA Medical II and JETT Medical II.