<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
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    <basicUdiDi>5032384StrepGroupReagD7</basicUdiDi>
    <tradeName>EXTRACTION ENZYME</tradeName>
    <deviceName>EXTRACTION ENZYME</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR0593G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:07:38.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>05032384519828</udiDi>
    <basicUdiDi>5032384ProSpecTWashDM</basicUdiDi>
    <tradeName>PROSPECT WASH BUFFER</tradeName>
    <deviceName>PROSPECT WASH BUFFER</deviceName>
    <manufacturerName>Oxoid Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016914</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R2450001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:06:45.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987815008772</udiDi>
    <basicUdiDi>4987815TB02A3</basicUdiDi>
    <tradeName>Capilia TB-Neo Extraction Buffer 20mL/Bottle</tradeName>
    <deviceName>Capilia TB-Neo Extraction Buffer</deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CATB0877</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:43:40.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRUVCUCS1</udiDi>
    <basicUdiDi>++EVIRSubstrateKT</basicUdiDi>
    <tradeName>ViraChip Chromogen / Substrate Solution</tradeName>
    <deviceName>Substrate</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-UVCUCS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:31.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>EVIRUVCAKI1</udiDi>
    <basicUdiDi>++EVIRConjugate5E</basicUdiDi>
    <tradeName>ViraChip® AP-Anti-Human IgA Conjugate</tradeName>
    <deviceName>Conjugate</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-UVCAKI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:25.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EVIRUVCPWP1</udiDi>
    <basicUdiDi>++EVIRReagentwithoutCoT8P</basicUdiDi>
    <tradeName>ViraChip Wash Buffer Plus</tradeName>
    <deviceName>Universal Reagent without Cells or Tissues</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-UVCPWP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:21:36.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EVIRUVCPPP1</udiDi>
    <basicUdiDi>++EVIRReagentwithCoTQB</basicUdiDi>
    <tradeName>ViraChip Sample Buffer Plus</tradeName>
    <deviceName>Universal Reagent with Cells or Tissues or Derivatives thereof</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-UVCPPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:21:35.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIWE2000809</udiDi>
    <basicUdiDi>++ENTIWE20008V037L</basicUdiDi>
    <tradeName>Verd.-/Waschpuffer  Dilution-/Washbuffer LINE</tradeName>
    <deviceName>Verd.-/Waschpuffer  Dilution-/Washbuffer LINE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE200.08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:25.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIWE2000203</udiDi>
    <basicUdiDi>++ENTIWE20002V036A</basicUdiDi>
    <tradeName>Substrat/Substrate LINE</tradeName>
    <deviceName>Substrat/Substrate LINE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE200.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:23.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIWE4004209</udiDi>
    <basicUdiDi>++ENTIWE400X2V02LT</basicUdiDi>
    <tradeName>IgA Konjugat/Conjugate (anti-human) LINE</tradeName>
    <deviceName>IgG Konjugat/Conjugate (anti-human) LINE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE400.42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:23.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTIW00000S</udiDi>
    <basicUdiDi>++ENTIW0000V018B</basicUdiDi>
    <tradeName>Washing Buffer (20x concentrated)</tradeName>
    <deviceName>Washing Buffer (20x concentrated)</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:05.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI16110106</udiDi>
    <basicUdiDi>++ENTI16110XV02YC</basicUdiDi>
    <tradeName>RF-SorboTech</tradeName>
    <deviceName>RF-SorboTech</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>161101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:04.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI15110105</udiDi>
    <basicUdiDi>++ENTI151101V03PH</basicUdiDi>
    <tradeName>TMB-Substrat/Substrate ELISA</tradeName>
    <deviceName>TMB-Substrat/Substrate ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:03.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI14130106</udiDi>
    <basicUdiDi>++ENTI141X01V036F</basicUdiDi>
    <tradeName>PBS-Verdünnungspuffer/Dilution Buffer ELISA</tradeName>
    <deviceName>PBS-Verdünnungspuffer/Dilution Buffer ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:02.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI14120105</udiDi>
    <basicUdiDi>++ENTI141201V02P9</basicUdiDi>
    <tradeName>PBS-Waschlösung/Washing Solution ELISA</tradeName>
    <deviceName>PBS-Waschlösung/Washing Solution ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:08:58.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI14110104</udiDi>
    <basicUdiDi>++ENTI141101V03NW</basicUdiDi>
    <tradeName>Citrat Stopplösung/Stopping Solution ELISA</tradeName>
    <deviceName>Citrat Stopplösung/Stopping Solution ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:08:57.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI13110103</udiDi>
    <basicUdiDi>++ENTI131X01V025S</basicUdiDi>
    <tradeName>IgG Konjugat/Conjugate (anti-human) ELISA</tradeName>
    <deviceName>IgA Konjugat/Conjugate (anti-human) ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>131101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:08:57.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-81531100057769</udiDi>
    <basicUdiDi>B-81531100057769</basicUdiDi>
    <tradeName>Reveal Rapid HIV Test</tradeName>
    <deviceName>Reveal Rapid HIV Test</deviceName>
    <manufacturerName>MedMira Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000013928</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>815311000577</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:10.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057723370592</udiDi>
    <basicUdiDi>B-08057723370592</basicUdiDi>
    <tradeName>08057723370592</tradeName>
    <deviceName>SMART SNP Sample Diluent</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SNPD-SD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:27.035Z</lastUpdated>
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  <row>
    <udiDi>08057723370561</udiDi>
    <basicUdiDi>B-08057723370561</basicUdiDi>
    <tradeName>08057723370561</tradeName>
    <deviceName>SensiQuant Direct CELL Buffer</deviceName>
    <manufacturerName>BIOCLARMA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000030384</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SQTd-CB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:37:24.626Z</lastUpdated>
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</eudamedExport>