<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056080502076</udiDi>
    <basicUdiDi>50560805WellcoEDTAAY</basicUdiDi>
    <tradeName>WELLCOGEN EDTA SOLUTION</tradeName>
    <deviceName>WELLCOGEN EDTA SOLUTION</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30164501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:37.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501550</udiDi>
    <basicUdiDi>50560805StreptexCardM4</basicUdiDi>
    <tradeName>STREPTEX DISPOSABLE REACTION CARDS</tradeName>
    <deviceName>STREPTEX DISPOSABLE REACTION CARDS</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30368601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:36.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501543</udiDi>
    <basicUdiDi>50560805StapharexCardsBK</basicUdiDi>
    <tradeName>Staphaurex Disposable Reaction Cards (50 cards per pack)</tradeName>
    <deviceName>STAPHAUREX DISPOSABLE REACTION CARDS</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080399</emdnCode>
    <emdnDescription>IMMUNOLOGICAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30369001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:36.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501512</udiDi>
    <basicUdiDi>50560805StapharexPlusC6</basicUdiDi>
    <tradeName>Staphaurex Plus Latex Agglutination Test (150 tests)</tradeName>
    <deviceName>STAPHAUREX PLUS LATEX AGGLUTATION TEST</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080303</emdnCode>
    <emdnDescription>STAPHYLOCOCCI SLIDE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:35.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501499</udiDi>
    <basicUdiDi>50560805StapharexLD</basicUdiDi>
    <tradeName>Staphaurex Latex Agglutination Test (120 Tests)</tradeName>
    <deviceName>STAPHAUREX LATEX AGGLUTATION TEST</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080303</emdnCode>
    <emdnDescription>STAPHYLOCOCCI SLIDE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30859901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:34.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501482</udiDi>
    <basicUdiDi>50560805StreptexAcidExtAE</basicUdiDi>
    <tradeName>STREPTEX ACID EXTRACTION KIT</tradeName>
    <deviceName>STREPTEX ACID EXTRACTION KIT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30951301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:33.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501475</udiDi>
    <basicUdiDi>50560805StreptexEnzymeCU</basicUdiDi>
    <tradeName>STREPTEX EXTRACTION ENZYME</tradeName>
    <deviceName>STREPTEX EXTRACTION ENZYME</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30951001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:32.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501468</udiDi>
    <basicUdiDi>50560805StreptexPC63</basicUdiDi>
    <tradeName>STREPTEX POLYVALENT POSITIVE CONTROL</tradeName>
    <deviceName>STREPTEX POLYVALENT POSITIVE CONTROL</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30164601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:32.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501406</udiDi>
    <basicUdiDi>50560805StreptexLatexRS</basicUdiDi>
    <tradeName>STREPTEX LATEX A</tradeName>
    <deviceName>STREPTEX LATEX</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950601</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:31.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501390</udiDi>
    <basicUdiDi>50560805StreptexAcidL5</basicUdiDi>
    <tradeName>STREPTEX RAPID</tradeName>
    <deviceName>STREPTEX RAPID</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950555</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:30.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501376</udiDi>
    <basicUdiDi>50560805StreptexU9</basicUdiDi>
    <tradeName>STREPTEX</tradeName>
    <deviceName>STREPTEX</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30950501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:29.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501291</udiDi>
    <basicUdiDi>50560805PathoDXReagPCQV</basicUdiDi>
    <tradeName>PATHODX POSITIVE CONTROL</tradeName>
    <deviceName>PATHODX POSITIVE CONTROL</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R24042</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:28.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501239</udiDi>
    <basicUdiDi>50560805PathoDXStrep98</basicUdiDi>
    <tradeName>PATHODX STREP GROUPING KIT</tradeName>
    <deviceName>PATHODX STREP GROUPING KIT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62025</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:28.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080500492</udiDi>
    <basicUdiDi>50560805WCShigellaNK</basicUdiDi>
    <tradeName>Wellcolex Colour Shigella (50 tests)</tradeName>
    <deviceName>WELLCOLEX COLOUR SHIGELLA</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080301</emdnCode>
    <emdnDescription>SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30858401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:27.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080500485</udiDi>
    <basicUdiDi>50560805WCSalmonellaNB</basicUdiDi>
    <tradeName>Wellcolex Colour Salmonella (50 tests)</tradeName>
    <deviceName>WELLCOLEX COLOUR SALMONELLA</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080301</emdnCode>
    <emdnDescription>SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30858301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:26.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080500010</udiDi>
    <basicUdiDi>50560805PathoDXSlideHSV2N</basicUdiDi>
    <tradeName>PATHODX HERPES TYPING CONTROL SLIDES</tradeName>
    <deviceName>PATHODX HERPES TYPING CONTROL SLIDES</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62251</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:50:25.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501536</udiDi>
    <basicUdiDi>50560805PathoDXCardE6</basicUdiDi>
    <tradeName>PATHODX DISPOSABLE SLIDES</tradeName>
    <deviceName>PATHODX DISPOSABLE SLIDES</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:15.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501352</udiDi>
    <basicUdiDi>50560805PathDXStrepC7</basicUdiDi>
    <tradeName>PATHODX STREP GROUPING UNIVERSAL KIT</tradeName>
    <deviceName>PATHODX STREP GROUPING UNIVERSAL KIT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62076</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:14.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501307</udiDi>
    <basicUdiDi>50560805PathoDXReagGN</basicUdiDi>
    <tradeName>PATHODX EXTRACTION REAGENT 1</tradeName>
    <deviceName>PATHODX EXTRACTION REAGENT</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011199</emdnCode>
    <emdnDescription>STREPTOCOCCAL REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:14.124Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056080501246</udiDi>
    <basicUdiDi>50560805PathoDXLatex3G</basicUdiDi>
    <tradeName>PATHODX STREP A GROUPING LATEX</tradeName>
    <deviceName>PATHODX STREP GROUPING LATEX</deviceName>
    <manufacturerName>Remel Europe Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000016733</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R62030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:13.330Z</lastUpdated>
  </row>
</eudamedExport>