<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719878650021</udiDi>
    <basicUdiDi>471987865801-000VN</basicUdiDi>
    <tradeName>skyla</tradeName>
    <deviceName>skyla Hi Analyzer</deviceName>
    <manufacturerName>Skyla Corporation Hsinchu Science Park Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000007751</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801-000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:19:05.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719878650014</udiDi>
    <basicUdiDi>471987865800-001AVW</basicUdiDi>
    <tradeName>skyla</tradeName>
    <deviceName>skyla Clinical Chemistry Analyzer</deviceName>
    <manufacturerName>Skyla Corporation Hsinchu Science Park Branch</manufacturerName>
    <manufacturerSrn>TW-MF-000007751</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:19:03.760Z</lastUpdated>
  </row>
</eudamedExport>