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    <basicUdiDi>B-08588007926094</basicUdiDi>
    <tradeName>08588007926094</tradeName>
    <deviceName>COLI</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2002</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:16.094Z</lastUpdated>
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    <udiDi>08588007926087</udiDi>
    <basicUdiDi>B-08588007926087</basicUdiDi>
    <tradeName>08588007926087</tradeName>
    <deviceName>OXI</deviceName>
    <manufacturerName>Diagnostics s.r.o.</manufacturerName>
    <manufacturerSrn>SK-MF-000038255</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2001</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:23:14.500Z</lastUpdated>
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    <udiDi>00848838031151</udiDi>
    <basicUdiDi>8488380Pathotec7W</basicUdiDi>
    <tradeName>PATHOTEC CO (CYTOCHROME OXIDASE)</tradeName>
    <deviceName>PATHOTEC CO (CYTOCHROME OXIDASE)</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R38191</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:10.132Z</lastUpdated>
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    <udiDi>00848838028892</udiDi>
    <basicUdiDi>8488380PYRDiskXB</basicUdiDi>
    <tradeName>PYR 50 TEST KIT</tradeName>
    <deviceName>PYR TEST KIT</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30854301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:08.537Z</lastUpdated>
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    <udiDi>00848838028625</udiDi>
    <basicUdiDi>8488380LAPDiskJR</basicUdiDi>
    <tradeName>LAP 50 TEST KIT</tradeName>
    <deviceName>LAP TEST KIT</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30168501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:06.130Z</lastUpdated>
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    <udiDi>00848838023088</udiDi>
    <basicUdiDi>8488380NitrocefinDisk47</basicUdiDi>
    <tradeName>NITROCEFIN DISK</tradeName>
    <deviceName>NITROCEFIN DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R211667</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:22.846Z</lastUpdated>
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    <udiDi>00848838022746</udiDi>
    <basicUdiDi>8488380MicrodaseDiskAG</basicUdiDi>
    <tradeName>MICRODASE DISK</tradeName>
    <deviceName>MICRODASE DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21132</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:21.250Z</lastUpdated>
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    <udiDi>00848838022593</udiDi>
    <basicUdiDi>8488380CatarrhalisDiskQM</basicUdiDi>
    <tradeName>CATARRHALIS TEST DISK</tradeName>
    <deviceName>CATARRHALIS TEST DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:18.959Z</lastUpdated>
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    <udiDi>00848838022333</udiDi>
    <basicUdiDi>8488380HippurateDiskTV</basicUdiDi>
    <tradeName>HIPPURATE DISK</tradeName>
    <deviceName>HIPPURATE DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:09.238Z</lastUpdated>
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    <udiDi>15060392372828</udiDi>
    <basicUdiDi>50561527SV78MT</basicUdiDi>
    <tradeName>MAST®  Plasma Coagulase EDTA Selectavial</tradeName>
    <deviceName>MAST®  Plasma Coagulase EDTA Selectavial</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SV78</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:56:03.725Z</lastUpdated>
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    <udiDi>15060392372750</udiDi>
    <basicUdiDi>50561527ETO4LC</basicUdiDi>
    <tradeName>15060392372750</tradeName>
    <deviceName>MAST® ID Oxidase Strips</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ETO4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:55:59.721Z</lastUpdated>
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    <udiDi>15060392370275</udiDi>
    <basicUdiDi>50561527D57PV</basicUdiDi>
    <tradeName>15060392370275</tradeName>
    <deviceName>MASTDISCS® ID Oxidase Discs</deviceName>
    <manufacturerName>Mast Group Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000025209</manufacturerSrn>
    <authorisedRepresentativeName>Mast Diagnostica GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005299</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D57C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:54:45.233Z</lastUpdated>
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  <row>
    <udiDi>04260760135671</udiDi>
    <basicUdiDi>42607601395.01125W</basicUdiDi>
    <tradeName>Oxidase strips (app.80pcs)</tradeName>
    <deviceName>Oxidase strips (app.80pcs)</deviceName>
    <manufacturerName>Solabia Xebios GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000054384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95.0112</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:22:07.708Z</lastUpdated>
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  <row>
    <udiDi>00848838028915</udiDi>
    <basicUdiDi>8488380PYRDiskXB</basicUdiDi>
    <tradeName>PYR 100 TEST KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30854401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:25:37.011Z</lastUpdated>
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