<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00863840000261</udiDi>
    <basicUdiDi>B-00863840000261</basicUdiDi>
    <tradeName>AmplideX DM1 Dx Kit</tradeName>
    <deviceName>AmplideX DM1 Dx Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010118</emdnCode>
    <emdnDescription>MYOTONIC DYSTROPHY TYPE 1 OR STEINERT'S DISEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>76048</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:01.422Z</lastUpdated>
  </row>
</eudamedExport>