Certificates.

Our solutions have already received certification in MedApp's key markets.

Approvals

Cleared where it counts.

We are a technology company operating in the medical field. Our innovative solutions are revolutionizing the way people's lives can be treated and saved.

We are developing technologies that support diagnostic imaging and next-generation digital medicine. Our solutions have already received certification in MedApp's key markets.

  • CE
    European Union

    CE

    CE is a marking placed on the product of a manufacturer whose product has been approved for marketing in the European Union. CE directives concern issues related to safety of use, health protection and environmental protection. By marking its product with the CE mark, the manufacturer declares that the product complies with the requirements of all directives relating to it. As a result, CarnaLife Holo and CarnaLife System software can be supplied to medical facilities throughout the European Union.

    CoversCarnaLife HoloCarnaLife System
  • ANVISA
    Brazil

    ANVISA

    ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian Health Regulatory Agency, is a cell affiliated with the Ministry of Health that coordinates the operation of the Brazilian Health Regulatory System (SNVS). MedApp S.A. holds certification issued by the Agency for the CarnaLife Holo software in Brazil.

    CoversCarnaLife Holo
  • FDA
    United States

    FDA

    The FDA (Food and Drug Administration) is the U.S. Food and Drug Administration that inspects food products, drugs and medical devices. In June 2022, MedApp submitted an application to the FDA to begin selling CarnaLife Holo software in the US market. The application was for the approval of CLH's holographic medical data visualization technology. The approval process was managed by a partner, Parexel International, which is experienced in this field. In May 2023, MedApp received FDA confirmation of compliance and thus CarnaLife Holo technology was approved for the US market.

    CoversCarnaLife Holo
  • NCAGE
    NATO OTAN

    NCAGE

    We hold the NATO Commercial and Government Entity (NCAGE) code. This means that MedApp S.A. software meets the requirements specified in the NATO Manual for Codification — ACodP-1 guidelines. The NCAGE certificate allows us to provide services or deliveries to NATO member states.

    CoversCarnaLife Holo

Want the detail behind the approvals?.

We will answer questions about the scope of certification, the documentation and deployments in your country.

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Aleja Juliusza Słowackiego 6/10

30-037 Kraków

Poland

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REGON: 260637552

KRS: 0000443282

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