Data / Medical devices / Czechia / COMPEX, spol. s r.o.
COMPEX, spol. s r.o.: FDA-registered device maker in Brno Mesto Brno, Czechia, 3 510(k) clearances
COMPEX, spol. s r.o. is registered with the FDA (registration 3013563737) in Brno Mesto Brno, Czechia. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013563737
- Address
- Palackeho trida 924/105, Brno Mesto Brno, Czechia, 61200
- Owner or operator
- COMPEX, spol. s r.o. (10054752)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 19, 2017
- Registered through
- 2026
- Brand names listed
- JETT Medical II, JETT Medical Plasma II
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Low Power Electrosurgical Devices For Skin Lesion Destruction | QVJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 22, 2025 | K240311 | JETT Medical II | GEI | Substantially Equivalent | Compex, Spol, S.R.O. | accessdata.fda.gov |
| March 14, 2023 | K213247 | JETT PLASMA Medical II | QVJ | Substantially Equivalent | Compex, Spol, S.R.O. | accessdata.fda.gov |
| June 7, 2000 | K001159 | HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL | GEI | Substantially Equivalent | Conmedcorp | accessdata.fda.gov |
Compare with other makers
- All makers of Low Power Electrosurgical Devices For Skin Lesion Destruction
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated January 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.