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    <tradeName>HYDROFLEX PLUS</tradeName>
    <deviceName>HYDROFLEX PLUS</deviceName>
    <manufacturerName>Tecan Austria GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000020241</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>30190374</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:34:44.973Z</lastUpdated>
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    <udiDi>30850076346103</udiDi>
    <basicUdiDi>0850076346Lumini-CET</basicUdiDi>
    <tradeName>CLIA-go Pro Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>CLIA-go Pro Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GR-036</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:36:48.676Z</lastUpdated>
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    <udiDi>00810039380529</udiDi>
    <basicUdiDi>081003938LDX0009YG</basicUdiDi>
    <tradeName>LDX</tradeName>
    <deviceName>Cholestech LDX™ Analyzer</deviceName>
    <manufacturerName>Alere San Diego, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008348</manufacturerSrn>
    <authorisedRepresentativeName>Abbott Rapid Dx International Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000091</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14-875</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:38:25.827Z</lastUpdated>
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    <udiDi>D-2017MCQK</udiDi>
    <basicUdiDi>B-2017MCQK</basicUdiDi>
    <tradeName>mariPOC® Gastro control samples</tradeName>
    <deviceName>mariPOC® Gastro control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2017MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T11:27:36.263Z</lastUpdated>
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    <udiDi>D-1204SCQQ</udiDi>
    <basicUdiDi>B-1204SCQQ</basicUdiDi>
    <tradeName>mariPOC® SARS-2 control samples</tradeName>
    <deviceName>mariPOC® SARS-2 control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1204SC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:52:57.785Z</lastUpdated>
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  <row>
    <udiDi>D-1124MCQ9</udiDi>
    <basicUdiDi>B-1124MCQ9</basicUdiDi>
    <tradeName>mariPOC® Pharyn control samples</tradeName>
    <deviceName>mariPOC® Pharyn control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1124MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:55.845Z</lastUpdated>
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    <udiDi>D-1104MCPT</udiDi>
    <basicUdiDi>B-1104MCPT</basicUdiDi>
    <tradeName>mariPOC® RTI control samples</tradeName>
    <deviceName>mariPOC® RTI control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1104MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:47:31.018Z</lastUpdated>
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    <udiDi>08809408862782</udiDi>
    <basicUdiDi>88094088SEP-001TD</basicUdiDi>
    <tradeName>08809408862782</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEPD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:43.209Z</lastUpdated>
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    <udiDi>08809408862041</udiDi>
    <basicUdiDi>88094088SEY-001WG</basicUdiDi>
    <tradeName>08809408862041</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEYD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:42.412Z</lastUpdated>
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    <udiDi>08809408861631</udiDi>
    <basicUdiDi>88094088SBT-001TJ</basicUdiDi>
    <tradeName>08809408861631</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBTD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:36.812Z</lastUpdated>
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    <udiDi>8435287393507</udiDi>
    <basicUdiDi>843528739350HZ</basicUdiDi>
    <tradeName>TEMIS Semi-automatic Clinical Analyzer</tradeName>
    <deviceName>TEMIS Semi-automatic Clinical Analyzer</deviceName>
    <manufacturerName>Linear Chemicals S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000003284</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1803050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:58:25.044Z</lastUpdated>
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    <udiDi>06971792050099</udiDi>
    <basicUdiDi>697179205CF7</basicUdiDi>
    <tradeName>06971792050099</tradeName>
    <deviceName>Fully Automatic Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RL-C2000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T09:17:05.084Z</lastUpdated>
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    <udiDi>06430080370528</udiDi>
    <basicUdiDi>6430080371224MCCF</basicUdiDi>
    <tradeName>mariPOC® Quick Flu+ control samples</tradeName>
    <deviceName>mariPOC® Quick Flu+ control samples</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1224MC</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:40.924Z</lastUpdated>
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    <udiDi>06430080370481</udiDi>
    <basicUdiDi>643008037A-44W9</basicUdiDi>
    <tradeName>mariPOC® Filtration unit rack</tradeName>
    <deviceName>mariPOC®  Filtration unit rack</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-44</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:40.118Z</lastUpdated>
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    <udiDi>06430080370474</udiDi>
    <basicUdiDi>643008037A-43W7</basicUdiDi>
    <tradeName>mariPOC® Test plate storage rack</tradeName>
    <deviceName>mariPOC®  Test plate storage rack</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-43</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:39.336Z</lastUpdated>
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    <udiDi>06430080370467</udiDi>
    <basicUdiDi>643008037A-29WD</basicUdiDi>
    <tradeName>mariPOC® Bottletop dispenser stand</tradeName>
    <deviceName>mariPOC® Bottletop dispenser stand</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-29</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:38.513Z</lastUpdated>
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    <udiDi>06430080370412</udiDi>
    <basicUdiDi>643008037AD7-020HF</basicUdiDi>
    <tradeName>mariPOC® Analyser</tradeName>
    <deviceName>mariPOC® Analyser</deviceName>
    <manufacturerName>ArcDia International Oy Ltd</manufacturerName>
    <manufacturerSrn>FI-MF-000007553</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD7-020</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:00:32.929Z</lastUpdated>
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    <tradeName>06971792050914</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Realy Tech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004716</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020299</emdnCode>
    <emdnDescription>LIMITED PANEL IMMUNOCHEMISTRY ANALYSERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RL-C4000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:42:16.595Z</lastUpdated>
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