3 Korean Covid | 合法醫療器材資訊網
2021年7月15日—ThreeKoreandiagnostickitmakerswillcompetetoselltheirCovid-19...PCL,andSugentechforpersonalusebythegeneralpublic.
Humasis’ Covid-19 self-test kit won German approval on July
7.
Three Korean diagnostic kit makers will compete to sell their Covid-19 self-test devices in Germany, which has the largest medical device industry in Europe.
Germany is one of the European countries where the competition for Covid-19 self-test kits is intense. However, the Korean companies anticipate that German consumers’ easy access to home test kits could lead to a steady supply.
According to the website of Germany’s regulator of drugs and medical devices, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany has granted approval to home test devices of Humasis, PCL, and Sugentech for personal use by the general public.
In Germany, a Covid-19 self-test device for the general public requires separate BfArM approval, in addition to CE certification. To...
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【凱爾格瑞光度量測化學分析儀】許可證字號:衛署醫器輸壹字第005784號
器材品名:凱爾格瑞光度量測化學分析儀許可證字號:衛署醫器輸壹字第005784號註銷狀態:已註銷註銷日期:2014/06/12註銷理由:許...