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<eudamedExport entity="devices">
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    <basicUdiDi>59991062NormaCont56F</basicUdiDi>
    <tradeName>H5-Check Normal control blood set for 5-part differential Hemolyzer® hematology analyzers - 6 normal vials</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE5505</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:58:00.763Z</lastUpdated>
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  <row>
    <udiDi>05999106200573</udiDi>
    <basicUdiDi>59991062NormaCalZ8</basicUdiDi>
    <tradeName>H3/5-CAL calibrator for Hemolyzer® hematology analyzers</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE3611</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:48:40.692Z</lastUpdated>
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  <row>
    <udiDi>D-053.003.0029F</udiDi>
    <basicUdiDi>B-053.003.0029F</basicUdiDi>
    <tradeName>Plasma/Low Hb Control '20.0'</tradeName>
    <deviceName>Plasma/Low Hb Control '20.0'</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>053.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:34:34.930Z</lastUpdated>
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    <udiDi>D-053.002.00294</udiDi>
    <basicUdiDi>B-053.002.00294</basicUdiDi>
    <tradeName>Plasma/Low Hb Control '5.0'</tradeName>
    <deviceName>Plasma/Low Hb Control '5.0'</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>053.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:34:34.132Z</lastUpdated>
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  <row>
    <udiDi>D-053.001.0028R</udiDi>
    <basicUdiDi>B-053.001.0028R</basicUdiDi>
    <tradeName>Plasma/Low Hb Control '1.0'</tradeName>
    <deviceName>Plasma/Low Hb Control '1.0'</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>053.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:34:30.130Z</lastUpdated>
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  <row>
    <udiDi>06944904032641</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002429-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.209Z</lastUpdated>
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  <row>
    <udiDi>06944904032658</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002430-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.193Z</lastUpdated>
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  <row>
    <udiDi>06944904032665</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002431-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.175Z</lastUpdated>
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  <row>
    <udiDi>06944904032672</udiDi>
    <basicUdiDi>69449040003NBC-RET*****3V</basicUdiDi>
    <tradeName>BC-RET Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002432-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:59.161Z</lastUpdated>
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  <row>
    <udiDi>03770008181007</udiDi>
    <basicUdiDi>B-03770008181007</basicUdiDi>
    <tradeName>03770008181007</tradeName>
    <deviceName>IJB K-Control</deviceName>
    <manufacturerName>Institut de Biotechnologies Jacques Boy</manufacturerName>
    <manufacturerSrn>FR-MF-000004609</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010599</emdnCode>
    <emdnDescription>HAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>908080564</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:21:12.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>04931921015445</udiDi>
    <basicUdiDi>4931921IVD0012NQ</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL for reticulocyte MK-RE2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:52.353Z</lastUpdated>
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  <row>
    <udiDi>04931921015452</udiDi>
    <basicUdiDi>4931921IVD0012NQ</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL for reticulocyte MK-RE3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:52.337Z</lastUpdated>
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  <row>
    <udiDi>04931921015469</udiDi>
    <basicUdiDi>4931921IVD0012NQ</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL for reticulocyte MK-RE3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REM04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:52.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>04931921026106</udiDi>
    <basicUdiDi>4931921IVD0010NL</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL+CRP MK-3CN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3CN06</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:51.997Z</lastUpdated>
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    <udiDi>04931921026113</udiDi>
    <basicUdiDi>4931921IVD0010NL</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL+CRP MK-3CN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3CN12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:51.974Z</lastUpdated>
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    <udiDi>04931921026120</udiDi>
    <basicUdiDi>4931921IVD0010NL</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL+CRP MK-3CL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3CLH3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:51.948Z</lastUpdated>
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    <udiDi>04931921026144</udiDi>
    <basicUdiDi>4931921IVD0010NL</basicUdiDi>
    <tradeName>HEMATOLOGY CONTROL+CRP MK-3CH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIHON KOHDEN CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000019022</manufacturerSrn>
    <authorisedRepresentativeName>NIHON KOHDEN EUROPE GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010740</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3CLH6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T16:17:51.923Z</lastUpdated>
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  <row>
    <udiDi>D-022.003.0025Z</udiDi>
    <basicUdiDi>B-022.003.0025Z</basicUdiDi>
    <tradeName>HemoTrol High (Level 3)</tradeName>
    <deviceName>HemoTrol High (Level 3)</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022.003.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:14:10.377Z</lastUpdated>
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  <row>
    <udiDi>D-022.002.0025N</udiDi>
    <basicUdiDi>B-022.002.0025N</basicUdiDi>
    <tradeName>HemoTrol Normal (Level 2)</tradeName>
    <deviceName>HemoTrol Normal (Level 2)</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022.002.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:14:08.791Z</lastUpdated>
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  <row>
    <udiDi>D-022.001.0025B</udiDi>
    <basicUdiDi>B-022.001.0025B</basicUdiDi>
    <tradeName>HemoTrol Low (Level 1)</tradeName>
    <deviceName>HemoTrol Low (Level 1)</deviceName>
    <manufacturerName>Eurotrol B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022.001.002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:14:06.397Z</lastUpdated>
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