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<eudamedExport entity="devices">
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    <basicUdiDi>8488380RapIDNitrateASG</basicUdiDi>
    <tradeName>RAPID NITRATE A REAGENT</tradeName>
    <deviceName>RAPID NITRATE A REAGENT</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8309003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:12.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838057830</udiDi>
    <basicUdiDi>8488380RapIDSpIndoleJT</basicUdiDi>
    <tradeName>RAPID INDOLE REAGENT</tradeName>
    <deviceName>RAPID INDOLE REAGENT</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R8309002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:10.927Z</lastUpdated>
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  <row>
    <udiDi>00848838023927</udiDi>
    <basicUdiDi>8488380BDrpVPBRW</basicUdiDi>
    <tradeName>BACTIDROP VOGES-PROSKAUER B</tradeName>
    <deviceName>BACTIDROP VOGES-PROSKAUER B</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21562</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:04.526Z</lastUpdated>
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  <row>
    <udiDi>00848838023910</udiDi>
    <basicUdiDi>8488380BDrpVPARU</basicUdiDi>
    <tradeName>BACTIDROP VOGES-PROSKAUER A</tradeName>
    <deviceName>BACTIDROP VOGES-PROSKAUER A</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21560</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:03.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023903</udiDi>
    <basicUdiDi>8488380BDrpSpotIndole3C</basicUdiDi>
    <tradeName>BACTIDROP SPOT INDOLE</tradeName>
    <deviceName>BACTIDROP SPOT INDOLE</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21550</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:01.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023880</udiDi>
    <basicUdiDi>8488380BDrpOxidaseHR</basicUdiDi>
    <tradeName>BACTIDROP OXIDASE</tradeName>
    <deviceName>BACTIDROP 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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21540</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:58.919Z</lastUpdated>
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  <row>
    <udiDi>00848838023873</udiDi>
    <basicUdiDi>8488380BDrpNitrateB6Q</basicUdiDi>
    <tradeName>BACTIDROP NITRATE B</tradeName>
    <deviceName>BACTIDROP NITRATE B</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21538</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:57.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023866</udiDi>
    <basicUdiDi>8488380BDrpNitrateA6N</basicUdiDi>
    <tradeName>BACTIDROP NITRATE A</tradeName>
    <deviceName>BACTIDROP NITRATE A</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21536</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:56.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023859</udiDi>
    <basicUdiDi>8488380BDrpNinhydrin2Q</basicUdiDi>
    <tradeName>BACTIDROP NINHYDRIN</tradeName>
    <deviceName>BACTIDROP NINHYDRIN</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21534</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:54.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023828</udiDi>
    <basicUdiDi>8488380BDrpKOHQG</basicUdiDi>
    <tradeName>BACTIDROP KOH (10%)</tradeName>
    <deviceName>BACTIDROP KOH</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21524</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:50.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023811</udiDi>
    <basicUdiDi>8488380BDrpIndoleKovP2</basicUdiDi>
    <tradeName>BACTIDROP INDOLE (KOVACS)</tradeName>
    <deviceName>BACTIDROP INDOLE (KOVACS)</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21522</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:47.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838023781</udiDi>
    <basicUdiDi>8488380BDrpFeChlorideXU</basicUdiDi>
    <tradeName>BACTIDROP FERRIC CHLORIDE (10%)</tradeName>
    <deviceName>BACTIDROP FERRIC CHLORIDE</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>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21514</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:43.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435256762730</udiDi>
    <basicUdiDi>8435421200523XV</basicUdiDi>
    <tradeName>master diagnóstica</tradeName>
    <deviceName>Polyacrylamide (10%) Gel Electrophoresis Kit</deviceName>
    <manufacturerName>VITRO, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019002</emdnCode>
    <emdnDescription>ELECTROPHORESIS MEDIA (UNASSIGNABLE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAD-003990M-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:00:57.334Z</lastUpdated>
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  <row>
    <udiDi>08435256762464</udiDi>
    <basicUdiDi>8435421200522XT</basicUdiDi>
    <tradeName>master diagnóstica</tradeName>
    <deviceName>Polyacrylamide (8%) Gel Electrophoresis Kit</deviceName>
    <manufacturerName>VITRO, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019002</emdnCode>
    <emdnDescription>ELECTROPHORESIS MEDIA (UNASSIGNABLE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAD-003990M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:00:56.477Z</lastUpdated>
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  <row>
    <udiDi>08435256759334</udiDi>
    <basicUdiDi>8435421200521XR</basicUdiDi>
    <tradeName>master diagnóstica</tradeName>
    <deviceName>Agarose Gel DNA Electrophoresis Kit</deviceName>
    <manufacturerName>VITRO, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001498</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019002</emdnCode>
    <emdnDescription>ELECTROPHORESIS MEDIA (UNASSIGNABLE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAD-003980M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:00:52.471Z</lastUpdated>
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    <udiDi>08430793041157</udiDi>
    <basicUdiDi>84307930411573H</basicUdiDi>
    <tradeName>Aptiva® System Rinse</tradeName>
    <deviceName>Aptiva® System Rinse</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:26:15.762Z</lastUpdated>
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    <udiDi>08430793041140</udiDi>
    <basicUdiDi>84307930411402Y</basicUdiDi>
    <tradeName>Aptiva® Optical Cleaning Solution</tradeName>
    <deviceName>Aptiva® Optical Cleaning Solution</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>AC1003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:26:14.960Z</lastUpdated>
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    <udiDi>08426950915782</udiDi>
    <basicUdiDi>84269509157829U</basicUdiDi>
    <tradeName>Distilled Water Additive</tradeName>
    <deviceName>Distilled Water Additive</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018468100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:13:04.370Z</lastUpdated>
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    <udiDi>08426950553625</udiDi>
    <basicUdiDi>84269505536258M</basicUdiDi>
    <tradeName>DRI Ethyl Alcohol</tradeName>
    <deviceName>DRI Ethyl Alcohol</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019099</emdnCode>
    <emdnDescription>CLINICAL CHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W150037</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:42.116Z</lastUpdated>
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    <udiDi>08426950553557</udiDi>
    <basicUdiDi>84269505535578V</basicUdiDi>
    <tradeName>Acid Cuvette Cleaner</tradeName>
    <deviceName>Acid Cuvette Cleaner</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01019001</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018468000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:40.517Z</lastUpdated>
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