<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IFR0002K00KN</udiDi>
    <basicUdiDi>B-IFR0002K00KN</basicUdiDi>
    <tradeName>AdvanSure™ i3 TB-IGRA Calibrator</tradeName>
    <deviceName>AdvanSure™ i3 TB-IGRA Calibrator</deviceName>
    <manufacturerName>Invitros Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000023980</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080999</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS - INF. IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFR0002K00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:26.030Z</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>
</eudamedExport>