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<eudamedExport entity="devices">
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    <udiDi>D-4018674GTCST01UUEW</udiDi>
    <basicUdiDi>B-4018674GTCST01UUEW</basicUdiDi>
    <tradeName>Geratherm® chlamydia check</tradeName>
    <deviceName>Geratherm® chlamydia check</deviceName>
    <manufacturerName>Geratherm Medical GERMANY GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007307</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010107</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9750000660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:06:11.617Z</lastUpdated>
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  <row>
    <udiDi>D-400-038-C-MAXQ3</udiDi>
    <basicUdiDi>B-400-038-C-MAXQ3</basicUdiDi>
    <tradeName>D-400-038-C-MAXQ3</tradeName>
    <deviceName>BioGX Syphilis - OSR for BD MAX</deviceName>
    <manufacturerName>BioGX B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000031736</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010305</emdnCode>
    <emdnDescription>SYPHILIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400-038-C-MAX</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:25.825Z</lastUpdated>
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    <udiDi>38594036044303</udiDi>
    <basicUdiDi>B-38594036044303</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Pseudomonas aeruginosa IgG</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>W0105010901</emdnCode>
    <emdnDescription>PSEUDOMONAS AERUGINOSA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-430-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:55:00.733Z</lastUpdated>
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    <udiDi>38594036044020</udiDi>
    <basicUdiDi>B-38594036044020</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgA</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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-402-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:58.242Z</lastUpdated>
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  <row>
    <udiDi>38594036044013</udiDi>
    <basicUdiDi>B-38594036044013</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae 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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-401-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:38.944Z</lastUpdated>
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    <udiDi>38594036044006</udiDi>
    <basicUdiDi>B-38594036044006</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Mycoplasma pneumoniae IgG</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>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-400-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:38.143Z</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>
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    <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>38594036042323</udiDi>
    <basicUdiDi>B-38594036042323</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Chlamydia pneumonieae IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010114</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIBODY IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-232-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:29.371Z</lastUpdated>
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  <row>
    <udiDi>38594036042316</udiDi>
    <basicUdiDi>B-38594036042316</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Chlamydia pneumonieae IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010116</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-231-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:24.534Z</lastUpdated>
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  <row>
    <udiDi>38594036042309</udiDi>
    <basicUdiDi>B-38594036042309</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Chlamydia pneumonieae IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010115</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONAIE ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-230-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:23.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>38594036042224</udiDi>
    <basicUdiDi>B-38594036042224</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Chlamydia trachomatis IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010109</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIBODY IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-222-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:22.942Z</lastUpdated>
  </row>
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    <udiDi>38594036042200</udiDi>
    <basicUdiDi>B-38594036042200</basicUdiDi>
    <tradeName>MONO-VIDITEST anti-Chlamydia trachomatis IgG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010110</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KZ-220-12</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:54:22.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-2R04ES</udiDi>
    <basicUdiDi>B-2R04ES</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile Toxin A/B test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile Toxin A/B test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011802</emdnCode>
    <emdnDescription>C.DIFFICILE TOXIN A/B DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R04</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:35.613Z</lastUpdated>
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    <udiDi>D-2R03EQ</udiDi>
    <basicUdiDi>B-2R03EQ</basicUdiDi>
    <tradeName>mariPOC® Clostridium difficile GDH test reagent</tradeName>
    <deviceName>mariPOC® Clostridium difficile GDH test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011801</emdnCode>
    <emdnDescription>C.DIFFICILE GDH DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R03</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:34.810Z</lastUpdated>
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  <row>
    <udiDi>D-2R02EN</udiDi>
    <basicUdiDi>B-2R02EN</basicUdiDi>
    <tradeName>mariPOC® Campylobacter spp. test reagent</tradeName>
    <deviceName>mariPOC® Campylobacter spp. test reagent</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011401</emdnCode>
    <emdnDescription>CAMPYLOBACTER DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2R02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:58:34.009Z</lastUpdated>
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    <udiDi>28594036045266</udiDi>
    <basicUdiDi>B-28594036045266</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Pseudomonas aeruginosa IgG</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>W0105010901</emdnCode>
    <emdnDescription>PSEUDOMONAS AERUGINOSA ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-526</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:21.937Z</lastUpdated>
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    <udiDi>28594036044658</udiDi>
    <basicUdiDi>B-28594036044658</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Chlamydia trachomatis IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010109</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS ANTIBODY IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-465</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:04.855Z</lastUpdated>
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    <udiDi>28594036044597</udiDi>
    <basicUdiDi>B-28594036044597</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Chlamydia pneumoniae IgA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010114</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIBODY IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-459</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:04.042Z</lastUpdated>
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    <udiDi>28594036044580</udiDi>
    <basicUdiDi>B-28594036044580</basicUdiDi>
    <tradeName>ELISA-VIDITEST anti-Chlamydia pneumoniae IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VIDIA spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000036964</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010116</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODZ-458</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:22:03.243Z</lastUpdated>
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