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    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS106LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:30.995Z</lastUpdated>
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    <udiDi>08435440215615</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_SCSSP</basicUdiDi>
    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS106HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:22.645Z</lastUpdated>
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    <udiDi>08435440215592</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_SCSSP</basicUdiDi>
    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS112LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:22.176Z</lastUpdated>
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    <udiDi>08435440215622</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_SCSSP</basicUdiDi>
    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS112HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:21.621Z</lastUpdated>
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    <udiDi>08435440215608</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_SCSSP</basicUdiDi>
    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS113LE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:52.854Z</lastUpdated>
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    <udiDi>08435440215639</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_SCSSP</basicUdiDi>
    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS113HE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:51.707Z</lastUpdated>
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    <udiDi>08435440215653</udiDi>
    <basicUdiDi>84354402_MDXGASTROB_SCSSP</basicUdiDi>
    <tradeName>VIASURE Salmonella, Campylobacter &amp; Shigella/EIEC Real Time PCR Detection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CERTEST BIOTEC S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000002193</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS-SCS196TE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:43.783Z</lastUpdated>
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    <udiDi>D-GBS-P1-10Y4</udiDi>
    <basicUdiDi>B-GBS-P1-10Y4</basicUdiDi>
    <tradeName>GBS Test</tradeName>
    <deviceName>GBS Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBS-P1-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T00:29:21.426Z</lastUpdated>
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  <row>
    <udiDi>15420045517509</udiDi>
    <basicUdiDi>54200455DIAGPFGIEXPBACUK</basicUdiDi>
    <tradeName>Panther Fusion GI Expanded Bacterial Assay</tradeName>
    <deviceName>Panther Fusion GI Expanded Bacterial Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07121</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:47.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>15420045517486</udiDi>
    <basicUdiDi>54200455DIAGPFGIBACUY</basicUdiDi>
    <tradeName>Panther Fusion GI Bacterial Assay</tradeName>
    <deviceName>Panther Fusion GI Bacterial Assay</deviceName>
    <manufacturerName>Hologic</manufacturerName>
    <manufacturerSrn>US-MF-000001646</manufacturerSrn>
    <authorisedRepresentativeName>Hologic BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000127</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRD-07113</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:02:45.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>04053228045519</udiDi>
    <basicUdiDi>4053228RGI2QST000000001RK</basicUdiDi>
    <tradeName>QIAstat-Dx Gastrointestinal Panel 2</tradeName>
    <deviceName>QIAstat-Dx Gastrointestinal Panel 2</deviceName>
    <manufacturerName>QIAGEN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004949</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>691413</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:31:44.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GI05021WXQ</udiDi>
    <basicUdiDi>B-GI05021WXQ</basicUdiDi>
    <tradeName>Cowingene Diarrhea Virus Panel 6 Detection Kit</tradeName>
    <deviceName>Cowingene Diarrhea Virus Panel 6 Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GI05021W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:28.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GI04HR</udiDi>
    <basicUdiDi>B-GI04HR</basicUdiDi>
    <tradeName>Cowingene Enterovirus Universal, EV71 and  CoxA16 Detection Kit</tradeName>
    <deviceName>Cowingene Enterovirus Universal, EV71 and  CoxA16 Detection Kit</deviceName>
    <manufacturerName>Taizhou Cowingene Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000042619</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GI04021X, GI04022X, GI04023W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:36:27.053Z</lastUpdated>
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  <row>
    <udiDi>D-G2M803621FT</udiDi>
    <basicUdiDi>B-G2M803621FT</basicUdiDi>
    <tradeName>GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal</tradeName>
    <deviceName>GCP-Q comprehensive Real Time PCR Kit for Gastrointestinal</deviceName>
    <manufacturerName>Genes 2Me Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000035953</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G2M803621,G2M803621R</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:45:17.191Z</lastUpdated>
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    <udiDi>D-D-FICRYGLD257D</udiDi>
    <basicUdiDi>B-D-FICRYGLD257D</basicUdiDi>
    <tradeName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</tradeName>
    <deviceName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-FICRYGLD25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:20.378Z</lastUpdated>
  </row>
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    <udiDi>D-D-FICRYGLD106Y</udiDi>
    <basicUdiDi>B-D-FICRYGLD106Y</basicUdiDi>
    <tradeName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</tradeName>
    <deviceName>Cryptosporidium Ag and Giardia Lamblia Ag  Combo Test Device-Feces</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-FICRYGLD10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T11:15:18.775Z</lastUpdated>
  </row>
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    <udiDi>D-CRE-P5-10Y6</udiDi>
    <basicUdiDi>B-CRE-P5-10Y6</basicUdiDi>
    <tradeName>CRE Test</tradeName>
    <deviceName>CRE test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRE-P5-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:20:19.294Z</lastUpdated>
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    <udiDi>08809240101681</udiDi>
    <basicUdiDi>924010GI97010FP</basicUdiDi>
    <tradeName>Allplex™ GI-Virus Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Seegene, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000022275</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GI9701X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T03:45:22.681Z</lastUpdated>
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    <udiDi>09351179001505</udiDi>
    <basicUdiDi>B-09351179001505</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001H-MT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:20.973Z</lastUpdated>
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    <udiDi>09351179001475</udiDi>
    <basicUdiDi>B-09351179001475</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen™ Pan-Enteric Pathogen Detection Kit (PE001)</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PE001G-MT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:48:19.445Z</lastUpdated>
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