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<eudamedExport entity="devices">
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    <udiDi>D-75471903C</udiDi>
    <basicUdiDi>B-75471903C</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName>COULTER 4C-ES Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547190</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:09.777Z</lastUpdated>
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  <row>
    <udiDi>D-75471893T</udiDi>
    <basicUdiDi>B-75471893T</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName>COULTER 4C-ES Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547189</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:08.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471883R</udiDi>
    <basicUdiDi>B-75471883R</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName>COULTER 4C-ES Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547188</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:07.382Z</lastUpdated>
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  <row>
    <udiDi>D-75471873P</udiDi>
    <basicUdiDi>B-75471873P</basicUdiDi>
    <tradeName>COULTER 4C-ES Cell Control</tradeName>
    <deviceName>COULTER 4C-ES Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547187</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:05.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471252Z</udiDi>
    <basicUdiDi>B-75471252Z</basicUdiDi>
    <tradeName>Coulter Retic-C Cell Control</tradeName>
    <deviceName>Coulter Retic-C Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:00.270Z</lastUpdated>
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  <row>
    <udiDi>D-75469794R</udiDi>
    <basicUdiDi>B-75469794R</basicUdiDi>
    <tradeName>Coulter Retic-C Cell Control</tradeName>
    <deviceName>Coulter Retic-C Cell Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7546979</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:35.362Z</lastUpdated>
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  <row>
    <udiDi>D-75469153X</udiDi>
    <basicUdiDi>B-75469153X</basicUdiDi>
    <tradeName>Latron Primer I</tradeName>
    <deviceName>Latron Primer I</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7546915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:34.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75469143V</udiDi>
    <basicUdiDi>B-75469143V</basicUdiDi>
    <tradeName>Latron Control 2</tradeName>
    <deviceName>Latron Control 2</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7546914</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:31.719Z</lastUpdated>
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  <row>
    <udiDi>D-723503PU</udiDi>
    <basicUdiDi>B-723503PU</basicUdiDi>
    <tradeName>COULTER LIN-C Linearity Controls</tradeName>
    <deviceName>COULTER LIN-C Linearity Controls</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>723503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T05:59:54.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465996S4</udiDi>
    <basicUdiDi>B-465996S4</basicUdiDi>
    <tradeName>SYNCHRON Systems Ammonia/Alcohol Control Level 3</tradeName>
    <deviceName>SYNCHRON Systems Ammonia/Alcohol Control Level 3</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465996</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:44.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465993RW</udiDi>
    <basicUdiDi>B-465993RW</basicUdiDi>
    <tradeName>SYNCHRON Systems Ammonia/Alcohol Control Level 2</tradeName>
    <deviceName>SYNCHRON Systems Ammonia/Alcohol Control Level 2</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465993</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:43.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-465990RQ</udiDi>
    <basicUdiDi>B-465990RQ</basicUdiDi>
    <tradeName>SYNCHRON Systems Ammonia/Alcohol Control Level 1</tradeName>
    <deviceName>SYNCHRON Systems Ammonia/Alcohol Control Level 1</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>465990</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:42.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287112191</udiDi>
    <basicUdiDi>B-08435287112191</basicUdiDi>
    <tradeName>08435287112191</tradeName>
    <deviceName>COAGULATION CALIBRATOR</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61015</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:43.060Z</lastUpdated>
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  <row>
    <udiDi>08435287112184</udiDi>
    <basicUdiDi>B-08435287112184</basicUdiDi>
    <tradeName>08435287112184</tradeName>
    <deviceName>COAGULATION CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:42.257Z</lastUpdated>
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  <row>
    <udiDi>08435287112177</udiDi>
    <basicUdiDi>B-08435287112177</basicUdiDi>
    <tradeName>08435287112177</tradeName>
    <deviceName>COAGULATION CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61012</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:46:41.465Z</lastUpdated>
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  <row>
    <udiDi>08435287100389</udiDi>
    <basicUdiDi>B-08435287100389</basicUdiDi>
    <tradeName>08435287100389</tradeName>
    <deviceName>COAGULATION CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61008</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:41:03.538Z</lastUpdated>
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    <udiDi>08435287100372</udiDi>
    <basicUdiDi>B-08435287100372</basicUdiDi>
    <tradeName>08435287100372</tradeName>
    <deviceName>COAGULATION CONTROL I/II</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61007</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:41:02.745Z</lastUpdated>
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    <udiDi>08435287100365</udiDi>
    <basicUdiDi>B-08435287100365</basicUdiDi>
    <tradeName>08435287100365</tradeName>
    <deviceName>COAGULATION CALIBRATOR</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61006</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:41:01.948Z</lastUpdated>
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    <udiDi>06976117451926</udiDi>
    <basicUdiDi>B-06976117451926</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0071-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:30:33.148Z</lastUpdated>
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    <udiDi>06975679490671</udiDi>
    <basicUdiDi>B-06975679490671</basicUdiDi>
    <tradeName>Quality Control for Hematology Analyzer</tradeName>
    <deviceName>Quality Control for Hematology Analyzer</deviceName>
    <manufacturerName>Hunan Ehome Health Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045177</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YH-QC502</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:41:33.247Z</lastUpdated>
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