<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942202208973</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Probe Conditioning Solution</tradeName>
    <deviceName>Chemiluminescence Immunoassay Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3023059</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:30.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942202208966</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Acid Trigger Reagent</tradeName>
    <deviceName>Chemiluminescence Immunoassay Reagent</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3023060</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:51:29.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937455448658</udiDi>
    <basicUdiDi>697737643DD23MY</basicUdiDi>
    <tradeName>06937455448658</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Talent  Biomedical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000039397</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DD43-600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T20:35:07.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577436</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Acid Trigger Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019963</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577443</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Alkaline Trigger Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019964</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577450</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Probe Conditioning Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019923</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925794577474</udiDi>
    <basicUdiDi>69257945W01029099R05H</basicUdiDi>
    <tradeName>Probe Washing Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3019944</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:14:43.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438147129973</udiDi>
    <basicUdiDi>B-06438147129973</basicUdiDi>
    <tradeName>DELFIA hAFP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A096-101</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:44.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250289513517</udiDi>
    <basicUdiDi>42502895BLOTSAllergyCCD7D</basicUdiDi>
    <tradeName>AESKUBLOTS® Allergy CCD Blocker</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesku.Diagnostics GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000026925</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420000.BULK5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:04:26.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987562515363</udiDi>
    <basicUdiDi>4987562HISCL-WASHDN</basicUdiDi>
    <tradeName>04987562515363</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AZ483688</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:22.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014597</udiDi>
    <basicUdiDi>08476270BAGRETFS</basicUdiDi>
    <tradeName>Reveal Decloaker, RTU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV1000MMRTU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014610</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>Tris Buffer Saline (TBS) Plus, 10X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TBS942M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014627</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>Automation Tween 20, 20X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWA20M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014634</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>Immunocare TBS Wash Buffer, 10X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWB943M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014641</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>TBS Automation Wash Buffer, 20X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWB945M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014658</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>TBS Automation Wash Buffer, 40X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWB946L2J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014665</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>20% Tween 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWN20Н</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014672</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>20% Tween 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWN20L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627014689</udiDi>
    <basicUdiDi>08476270BWASHBUF3Q</basicUdiDi>
    <tradeName>20% Tween 20</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TWN20M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>00847627024985</udiDi>
    <basicUdiDi>08476270BBDB200486</basicUdiDi>
    <tradeName>ONCORE Pro DAB Chromogen</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biocare Medical</manufacturerName>
    <manufacturerSrn>US-MF-000034581</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPRI6056KT180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T18:26:02.041Z</lastUpdated>
  </row>
</eudamedExport>