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<eudamedExport entity="devices">
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    <udiDi>D-ILY-R402MA</udiDi>
    <basicUdiDi>B-ILY-R402MA</basicUdiDi>
    <tradeName>Lyme IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>Lyme IgG/IgM Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010602</emdnCode>
    <emdnDescription>LYME ANTIBODY TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILY-R402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:12:33.879Z</lastUpdated>
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  <row>
    <udiDi>48594036043990</udiDi>
    <basicUdiDi>B-48594036043990</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-399/5ST</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:09:56.721Z</lastUpdated>
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    <udiDi>48594036043983</udiDi>
    <basicUdiDi>B-48594036043983</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-398/5ST</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:09:55.926Z</lastUpdated>
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    <udiDi>38594036043009</udiDi>
    <basicUdiDi>B-38594036043009</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Borrelia sp. IgG + VIsE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-300-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:34.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036043016</udiDi>
    <basicUdiDi>B-38594036043016</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Borrelia sp. IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-301-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:34.064Z</lastUpdated>
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  <row>
    <udiDi>28594036043989</udiDi>
    <basicUdiDi>B-28594036043989</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-398</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:52.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>28594036043996</udiDi>
    <basicUdiDi>B-28594036043996</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-399</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:21:49.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036043005</udiDi>
    <basicUdiDi>B-18594036043005</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Borrelia sp. IgG + VIsE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-300-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:50.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>18594036043012</udiDi>
    <basicUdiDi>B-18594036043012</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Borrelia sp. IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-301-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:25:47.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-114403M5</udiDi>
    <basicUdiDi>B-114403M5</basicUdiDi>
    <tradeName>Reagena C6 LYME IgM/IgG EIA</tradeName>
    <deviceName>Reagena C6 LYME IgM/IgG EIA</deviceName>
    <manufacturerName>Reagena Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002804</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010602</emdnCode>
    <emdnDescription>LYME ANTIBODY TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>114403</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:48:49.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548259868</udiDi>
    <basicUdiDi>B-08683548259868</basicUdiDi>
    <tradeName>LyoSens Lyme Disease Detection qPCR Kit</tradeName>
    <deviceName>Lyme Disease Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010605</emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LYO67</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:21:30.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548257932</udiDi>
    <basicUdiDi>B-08683548257932</basicUdiDi>
    <tradeName>ChainFor Lyme Disease Detection qPCR Kit</tradeName>
    <deviceName>Lyme Disease Detection qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010605</emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFP96</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:17:36.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036043992</udiDi>
    <basicUdiDi>B-08594036043992</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-399</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:27.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>08594036043985</udiDi>
    <basicUdiDi>B-08594036043985</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Borelia recombinant IgG + VIsE (CSF)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OD-398</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:45:26.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238911190</udiDi>
    <basicUdiDi>B-06974238911190</basicUdiDi>
    <tradeName>Lyme Borrelia IgG/IgM Rapid Test</tradeName>
    <deviceName>Lyme Borrelia IgG/IgM Rapid Test</deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLYM077T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T15:00:06.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974238910261</udiDi>
    <basicUdiDi>B-06974238910261</basicUdiDi>
    <tradeName>Borrelia Burgdorferi Antibody Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010602</emdnCode>
    <emdnDescription>LYME ANTIBODY TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HLYM004T</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:14.899Z</lastUpdated>
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    <udiDi>04250289504577</udiDi>
    <basicUdiDi>B-04250289504577</basicUdiDi>
    <tradeName>AESKUBLOTS® Borrelia-M</tradeName>
    <deviceName>AESKUBLOTS® Borrelia</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010604</emdnCode>
    <emdnDescription>LYME ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:15.430Z</lastUpdated>
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  <row>
    <udiDi>04250289504560</udiDi>
    <basicUdiDi>B-04250289504560</basicUdiDi>
    <tradeName>AESKUBLOTS® Borrelia-G</tradeName>
    <deviceName>AESKUBLOTS® Borrelia</deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010603</emdnCode>
    <emdnDescription>LYME ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:39:15.390Z</lastUpdated>
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    <udiDi>04050598003040</udiDi>
    <basicUdiDi>B-04050598003040</basicUdiDi>
    <tradeName>MutaPLEX® Borrelia, PCR</tradeName>
    <deviceName>MutaPLEX® Borrelia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010605</emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1917032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:42:24.798Z</lastUpdated>
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  <row>
    <udiDi>04050598002425</udiDi>
    <basicUdiDi>B-04050598002425</basicUdiDi>
    <tradeName>MutaPLEX® Borrelia, PCR</tradeName>
    <deviceName>MutaPLEX® Borrelia, PCR</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010605</emdnCode>
    <emdnDescription>LYME DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KG1917096</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:41:22.307Z</lastUpdated>
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