The current CE-mark applies to the professional use of the test platform Egoo.Health for sale on the European market.
Qlife CE-mark for COVID-19 test delayed 2-3 months – application for temporary approval in Denmark due to public health interest submitted
Qlife was originally expecting CE-mark for the product in October, but the company is now expecting approval within the coming two to three months. In the mean time, Qlife has submitted an application to the Danish Medicines Agency (Lægemiddelstyrelsen) for placing the company’s COVID-19 test on the market prior to CE-marking in a direct response to the pandemic “in the interest of the protection of health”
“Qlife like any other IVD company now has to follow the increased regulatory requirements to obtain sufficient data to support clinical evidence, however in order to address the immediate and critical need to create virus-free locations for especially elderly and vulnerable people, we have decided to apply for market approval in Denmark prior to CE-marking”, says Thomas Warthoe”, CEO Qlife.
This disclosure contains information that Qlife Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 30-10-2020 12:00 CET.
Qlife expects to CE mark its COVID-19 test for professional use in the Egoo.Health system within short.
Since May 2020, Qlife has been handling all testing for COVID-19 for professional football in Denmark.
On November 13, Qlife was informed that the Danish Medicines Agency (Lægemiddelstyrelsen) had rejected the application for temporay approval in Denmark “in the interest of health protection” for th
”We will do our utmost to protect the participating players against the coronavirus”, says Frank Smith, Covid-19 Officer, European Handball Federation Euro 2020 “It requires testing with high preci
Resolution on (A) employee option program; and (B) directed issue of warrants and approval of transfer of warrants
FINANCIAL SUMMARY - THIRD QUARTER 2020
In parallel to the ongoing process of preparing and putting together the dossier for the CE-mark, Qlife has submitted an application for placing the product on the market at this stage, as it offer
The Nomination Committee consists of the following persons, who together represent approximately 39 percent of the company's shares and votes.