SÚKL
Competent authority · Czechia · Prague
A national competent authority for medical devices under the EU MDR/IVDR — market surveillance, vigilance and EUDAMED registration oversight.
A national body that oversees the application of EU medical-device regulation in its country — market surveillance, vigilance, economic-operator validation and EUDAMED registration oversight, under MDR Articles 101–108.
Explore every authority and economic operator registered in Czechia.
A national body that oversees the application of EU medical-device regulation in its country — surveillance, vigilance, and registration oversight.
No — that's a notified body. A competent authority supervises the market; it does not issue device certificates.
Sourced directly from EUDAMED. This record was last updated Jun 25, 2026.
Operators whose registration was validated by this authority.
| Operator | Role | SRN | Country |
|---|---|---|---|
| Espeon, s.r.o. | Importer | CZ-IM-000001977 | CZ |
| Firma DOLEJŠÍ - AUTOTRAKČNÍ LEHÁTKA s.r.o. | Manufacturer | CZ-MF-000041813 | CZ |
| "BAXTTEKS-FARM" Limited Liability Company | Manufacturer | UZ-MF-000040406 | UZ |
| "ELASTIKUM" Limited Liability Company | Manufacturer | UZ-MF-000036753 | UZ |
| "FIRMA "TEСHNOCOMPLEХ" LIMITED LIABILITY COMPANY | Manufacturer | UA-MF-000034609 | UA |
| "OPTIMA SOBIRJON" Limited Liability Company | Manufacturer | UZ-MF-000032973 | UZ |