<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-EIM4291332HU</udiDi>
    <basicUdiDi>B-EIM4291332HU</basicUdiDi>
    <tradeName>D-EIM4291332HU</tradeName>
    <deviceName>HSV-1/2 IgM Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4291332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:55:46.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4291328J5</udiDi>
    <basicUdiDi>B-EIM4291328J5</basicUdiDi>
    <tradeName>D-EIM4291328J5</tradeName>
    <deviceName>HSV-2 IgG Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4291328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:55:45.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4291327J3</udiDi>
    <basicUdiDi>B-EIM4291327J3</basicUdiDi>
    <tradeName>D-EIM4291327J3</tradeName>
    <deviceName>HSV-1/2 IgG Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080899</emdnCode>
    <emdnDescription>CONTROLS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4291327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:55:44.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4283332HX</udiDi>
    <basicUdiDi>B-EIM4283332HX</basicUdiDi>
    <tradeName>D-EIM4283332HX</tradeName>
    <deviceName>HSV-1/2 IgM Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4283332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:55:37.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4283328J8</udiDi>
    <basicUdiDi>B-EIM4283328J8</basicUdiDi>
    <tradeName>D-EIM4283328J8</tradeName>
    <deviceName>HSV-2 IgG Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4283328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:55:36.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4283327J6</udiDi>
    <basicUdiDi>B-EIM4283327J6</basicUdiDi>
    <tradeName>D-EIM4283327J6</tradeName>
    <deviceName>HSV-1/2 IgG Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4283327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:55:32.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4282332HQ</udiDi>
    <basicUdiDi>B-EIM4282332HQ</basicUdiDi>
    <tradeName>D-EIM4282332HQ</tradeName>
    <deviceName>HSV-1/2 IgM Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4282332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:45.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4282328HZ</udiDi>
    <basicUdiDi>B-EIM4282328HZ</basicUdiDi>
    <tradeName>D-EIM4282328HZ</tradeName>
    <deviceName>HSV-2 IgG Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4282328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:44.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4282327HX</udiDi>
    <basicUdiDi>B-EIM4282327HX</basicUdiDi>
    <tradeName>D-EIM4282327HX</tradeName>
    <deviceName>HSV-1/2 IgG Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4282327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:43.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4282323HP</udiDi>
    <basicUdiDi>B-EIM4282323HP</basicUdiDi>
    <tradeName>D-EIM4282323HP</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Calibrators (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4282323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:39.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281332HH</udiDi>
    <basicUdiDi>B-EIM4281332HH</basicUdiDi>
    <tradeName>D-EIM4281332HH</tradeName>
    <deviceName>HSV-1/2 IgM Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281332</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:13.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281328HS</udiDi>
    <basicUdiDi>B-EIM4281328HS</basicUdiDi>
    <tradeName>D-EIM4281328HS</tradeName>
    <deviceName>HSV-2 IgG Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:12.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281327HQ</udiDi>
    <basicUdiDi>B-EIM4281327HQ</basicUdiDi>
    <tradeName>D-EIM4281327HQ</tradeName>
    <deviceName>HSV-1/2 IgG Calibrators</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:11.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4281323HG</udiDi>
    <basicUdiDi>B-EIM4281323HG</basicUdiDi>
    <tradeName>D-EIM4281323HG</tradeName>
    <deviceName>Treponema Pallidum Antibody (anti-TP) Calibrators (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4281323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:54:07.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDX-20-561BT</udiDi>
    <basicUdiDi>B-CDX-20-561BT</basicUdiDi>
    <tradeName>GenomEra® C. difficile Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-20-561</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:42.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC856RM</udiDi>
    <basicUdiDi>B-CC856RM</basicUdiDi>
    <tradeName>EB EA IgM Control</tradeName>
    <deviceName>EB EA IgM Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC856</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:23.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC855RK</udiDi>
    <basicUdiDi>B-CC855RK</basicUdiDi>
    <tradeName>EB VCA IgA Control</tradeName>
    <deviceName>EB VCA IgA Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC855</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:22.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC854RH</udiDi>
    <basicUdiDi>B-CC854RH</basicUdiDi>
    <tradeName>EB VCA IgM Control</tradeName>
    <deviceName>EB VCA IgM Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC854</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:21.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC853RF</udiDi>
    <basicUdiDi>B-CC853RF</basicUdiDi>
    <tradeName>EB VCA IgG Control</tradeName>
    <deviceName>EB VCA IgG Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC853</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:20.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CC852RD</udiDi>
    <basicUdiDi>B-CC852RD</basicUdiDi>
    <tradeName>EB NA IgA Control</tradeName>
    <deviceName>EB NA IgA Control</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC852</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:57:16.628Z</lastUpdated>
  </row>
</eudamedExport>