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Medomics Medical SARS-CoV-2 Antigen Self-Testing Kit has obtained the EU CE certificate!

Medomics Medical SARS-CoV-2 Antigen Self-Testing Kit has obtained the EU CE certificate!

  • Categories:News Center
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  • Time of issue:2021-11-12
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(Summary description)

Medomics Medical SARS-CoV-2 Antigen Self-Testing Kit has obtained the EU CE certificate!

(Summary description)

  • Categories:News Center
  • Author:
  • Origin:
  • Time of issue:2021-11-12
  • Views:0
Information

On November 2, the new coronavirus antigen self-testing product SARS-CoV-2 Antigen Test Kit (LFIA) independently developed by Medomics Medical obtained the CE certificate issued by the notified body, which means that Medomics Medical self-testing product for new coronavirus antigen has been fully complies with the IVDD directive and the latest EU MDCG2021-21 regulations, and can be sold in the self-testing market in the EU and countries that recognize the EU CE certification.

 

 

The CE certificate obtained this time is a medical device product authorization specifically for ordinary individual users (non-professionals). It is very different from the professional version of the self-conformance declaration certificate used in medical institutions. The former benefits a wider range of people and the validity period of the certificate continues until 2025.

 

 

The new coronavirus antigen self-testing kit developed and produced by Medomics Medical has the advantages of high accuracy of test results, easy operation and small size and easy to carry. It can be operated by individuals themselves by collecting samples of nasal cavity swabs, which is fast in 15 minutes. The results are available to facilitate individuals and families to quickly and timely detect new coronary pneumonia. It can greatly improve the efficiency of individual testing, reduce the risk of cross-infection caused by crowd movement, and ease the service pressure of hospitals and other testing institutions. Fully meet the needs of people around the world for home self-testing and self-management.

 

 

 

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