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<eudamedExport entity="devices">
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    <udiDi>00842768007767</udiDi>
    <basicUdiDi>0405686900988WQ</basicUdiDi>
    <tradeName>ProC Control Plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446096</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:55:41.609Z</lastUpdated>
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  <row>
    <udiDi>D-EBL2198001BG</udiDi>
    <basicUdiDi>B-EBL2198001BG</basicUdiDi>
    <tradeName>D-EBL2198001BG</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2198001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:28.977Z</lastUpdated>
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  <row>
    <udiDi>D-EBL2197001B9</udiDi>
    <basicUdiDi>B-EBL2197001B9</basicUdiDi>
    <tradeName>D-EBL2197001B9</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2197001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:28.171Z</lastUpdated>
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    <udiDi>D-EBL2196001B2</udiDi>
    <basicUdiDi>B-EBL2196001B2</basicUdiDi>
    <tradeName>D-EBL2196001B2</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2196001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:27.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2195001AT</udiDi>
    <basicUdiDi>B-EBL2195001AT</basicUdiDi>
    <tradeName>D-EBL2195001AT</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2195001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:23.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2194001AL</udiDi>
    <basicUdiDi>B-EBL2194001AL</basicUdiDi>
    <tradeName>D-EBL2194001AL</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2194001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:22.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2193001AD</udiDi>
    <basicUdiDi>B-EBL2193001AD</basicUdiDi>
    <tradeName>D-EBL2193001AD</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2193001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:21.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2192006AG</udiDi>
    <basicUdiDi>B-EBL2192006AG</basicUdiDi>
    <tradeName>D-EBL2192006AG</tradeName>
    <deviceName>D-Dimer &amp; FDP 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>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2192006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:21.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2192005AE</udiDi>
    <basicUdiDi>B-EBL2192005AE</basicUdiDi>
    <tradeName>D-EBL2192005AE</tradeName>
    <deviceName>D-Dimer &amp; FDP 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>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2192005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:16.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2192001A6</udiDi>
    <basicUdiDi>B-EBL2192001A6</basicUdiDi>
    <tradeName>D-EBL2192001A6</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2192001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:16.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2191008AD</udiDi>
    <basicUdiDi>B-EBL2191008AD</basicUdiDi>
    <tradeName>D-EBL2191008AD</tradeName>
    <deviceName>D-Dimer &amp; FDP 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>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2191008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:15.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2191007AB</udiDi>
    <basicUdiDi>B-EBL2191007AB</basicUdiDi>
    <tradeName>D-EBL2191007AB</tradeName>
    <deviceName>D-Dimer &amp; FDP 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>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2191007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:14.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21910019X</udiDi>
    <basicUdiDi>B-EBL21910019X</basicUdiDi>
    <tradeName>D-EBL21910019X</tradeName>
    <deviceName>Coagulation Quality Control Plasma (CQC)</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2191001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:10.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2183005AA</udiDi>
    <basicUdiDi>B-EBL2183005AA</basicUdiDi>
    <tradeName>D-EBL2183005AA</tradeName>
    <deviceName>D-Dimer Calibrator</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>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2183005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:09.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL2182005A3</udiDi>
    <basicUdiDi>B-EBL2182005A3</basicUdiDi>
    <tradeName>D-EBL2182005A3</tradeName>
    <deviceName>D-Dimer Calibrator</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>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2182005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:08.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21810069W</udiDi>
    <basicUdiDi>B-EBL21810069W</basicUdiDi>
    <tradeName>D-EBL21810069W</tradeName>
    <deviceName>Fibrinogen Degradation Product (FDP) Calibrator</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>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2181006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:08.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21810059U</udiDi>
    <basicUdiDi>B-EBL21810059U</basicUdiDi>
    <tradeName>D-EBL21810059U</tradeName>
    <deviceName>D-Dimer Calibrator</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>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2181005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:02.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CTRL-P6201-010J9</udiDi>
    <basicUdiDi>B-CTRL-P6201-010J9</basicUdiDi>
    <tradeName>TEControl A Plus</tradeName>
    <deviceName>CTRL</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A6201-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:36:37.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CTRL-P6101-010HQ</udiDi>
    <basicUdiDi>B-CTRL-P6101-010HQ</basicUdiDi>
    <tradeName>TEControl A</tradeName>
    <deviceName>CTRL</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6101-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:36:36.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CTRL-P6001-010H7</udiDi>
    <basicUdiDi>B-CTRL-P6001-010H7</basicUdiDi>
    <tradeName>TEControl N</tradeName>
    <deviceName>CONTROL</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6001-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T10:36:32.041Z</lastUpdated>
  </row>
</eudamedExport>