On February 24, 2021, the company Dialab spol. s r.o. obtained the exception of placing a medical device on the market in the Czech Republic. This exemption concerns two medical devices that can be used for self-testing on COVID-19 and their use is in the interest of public health protection. The application submitted to the Ministry of Health of the Czech Republic was prepared by MeDeCorp s.r.o., which provides Dialab spol. s r.o. medical device management.
The exception applies to the following two medical devices:
- Flowflex SARS-CoV-2 Antigen rapid test
- Insert DIAQUCIK COVID-19 Ag Cassette
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If you need to place medical device on the market, become familiar with the legislation of medical devices or need to provide comprehensive regulatory affairs in your company, do not hesitate to contact us by email: medecorp@medecorp.cz or via the online form at website www.medecorp.cz. Complete list of offered services can be found on our website. You can find a complete list of offered services on our website.