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<eudamedExport entity="devices">
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    <udiDi>04262420430225</udiDi>
    <basicUdiDi>426242043GEN111SF</basicUdiDi>
    <tradeName>FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)</tradeName>
    <deviceName>FR118-Human specific DNA-Internal Control (Realtime PCR-Kit)</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:41.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262420430010</udiDi>
    <basicUdiDi>426242043GEN222SR</basicUdiDi>
    <tradeName>FR799</tradeName>
    <deviceName>FR799-Identification of human specific ß-Actin</deviceName>
    <manufacturerName>Genekam Biotechnology AG</manufacturerName>
    <manufacturerSrn>DE-MF-000035227</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080908</emdnCode>
    <emdnDescription>STANDARDS AND CALIBRATORS FOR ALL INFECTIONS/ NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR799</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:32:37.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4291315KU</udiDi>
    <basicUdiDi>B-IM4291315KU</basicUdiDi>
    <tradeName>D-IM4291315KU</tradeName>
    <deviceName>HAV IgM Control</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4291315</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:13:04.791Z</lastUpdated>
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  <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>
  <row>
    <udiDi>D-A40706U2</udiDi>
    <basicUdiDi>B-A40706U2</basicUdiDi>
    <tradeName>Access CMV IgM, Calibrators</tradeName>
    <deviceName>Access CMV IgM, Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40706</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:24.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A40703TU</udiDi>
    <basicUdiDi>B-A40703TU</basicUdiDi>
    <tradeName>Access CMV IgG Calibrators</tradeName>
    <deviceName>Access CMV IgG Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A40703</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:21.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A31589UJ</udiDi>
    <basicUdiDi>B-A31589UJ</basicUdiDi>
    <tradeName>Access Toxo IgG Calibrators</tradeName>
    <deviceName>Access Toxo IgG Calibrators</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A31589</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:16:09.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34445GM</udiDi>
    <basicUdiDi>B-34445GM</basicUdiDi>
    <tradeName>Access RUBELLA IgM CALIBRATORS</tradeName>
    <deviceName>Access RUBELLA IgM CALIBRATORS</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080904</emdnCode>
    <emdnDescription>OTHER VIROLOGY STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34445</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:28:03.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-34250G4</udiDi>
    <basicUdiDi>B-34250G4</basicUdiDi>
    <tradeName>Access HBc IgM (Reagent Pack)</tradeName>
    <deviceName>Access HBc IgM (Reagent Pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080902</emdnCode>
    <emdnDescription>HEPATITIS VIRUS STANDARDS AND CALIBRATORS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34250</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:27:39.167Z</lastUpdated>
  </row>
</eudamedExport>