<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>D-69750225320171CEKHRT</udiDi>
    <basicUdiDi>B-69750225320171CEKHRT</basicUdiDi>
    <tradeName>D-69750225320171CEKHRT</tradeName>
    <deviceName>Blood Lactate Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN300R1、EN300R2、EN300R3、EN300R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:02.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487610ALTZR</udiDi>
    <basicUdiDi>B-47136487610ALTZR</basicUdiDi>
    <tradeName>THE EDGE</tradeName>
    <deviceName>THE EDGE blood lactate test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5638025</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:31.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105883ND</udiDi>
    <basicUdiDi>B-105883ND</basicUdiDi>
    <tradeName>Lactate Pro 2 Test Strip</tradeName>
    <deviceName>Lactate Pro 2 Test Strip</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105883</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:08.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-105882NB</udiDi>
    <basicUdiDi>B-105882NB</basicUdiDi>
    <tradeName>Lactate Pro 2 Test Strip</tradeName>
    <deviceName>Lactate Pro 2 Test Strip</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105882</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:06.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065133123</udiDi>
    <basicUdiDi>B-08800065133123</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Lactate Test Strip</tradeName>
    <deviceName>Lactate Test Strip</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400S12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:00.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065133024</udiDi>
    <basicUdiDi>B-08800065133024</basicUdiDi>
    <tradeName>CERA-CHEK™ Lactate Test Strip</tradeName>
    <deviceName>Lactate Test Strip</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L400S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:00.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719893238488</udiDi>
    <basicUdiDi>B-04719893238488</basicUdiDi>
    <tradeName>NOVAMA® PRO MultiCheck+ 5w1 BT WIELOPARAMETROWY MIERNIK KRWI PASKI TESTOWE MLECZAN</tradeName>
    <deviceName>Lactate Test Strips</deviceName>
    <manufacturerName>TaiDoc Technology Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000017956</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-4663</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:07:12.241Z</lastUpdated>
  </row>
</eudamedExport>