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<eudamedExport entity="devices">
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    <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>08592156113168</udiDi>
    <basicUdiDi>8592156HECAL303VM</basicUdiDi>
    <tradeName>ELite H CAL</tradeName>
    <deviceName>ELite H CAL</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00027</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:21.143Z</lastUpdated>
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  <row>
    <udiDi>06935740743501</udiDi>
    <basicUdiDi>69357407IBHS000026EE</basicUdiDi>
    <tradeName>URIT CA 11 Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:31.382Z</lastUpdated>
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    <udiDi>06970493096412</udiDi>
    <basicUdiDi>6970493090608007PY</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0006-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:25:07.893Z</lastUpdated>
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  <row>
    <udiDi>06970493096542</udiDi>
    <basicUdiDi>6970493090608008Q2</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0008-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:25:07.397Z</lastUpdated>
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  <row>
    <udiDi>13607450014003</udiDi>
    <basicUdiDi>3607450CALS0018F9</basicUdiDi>
    <tradeName>sthemA CAL-CBC</tradeName>
    <deviceName>sthemA CAL-CBC</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01400</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:00:14.991Z</lastUpdated>
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  <row>
    <udiDi>06975984062082</udiDi>
    <basicUdiDi>6970341680320200202JL</basicUdiDi>
    <tradeName>ß-THALASSAEMIA &amp; HbA1c Calibrator</tradeName>
    <deviceName>ß-THALASSAEMIA &amp; HbA1c Calibrator</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320200601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:17:34.592Z</lastUpdated>
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  <row>
    <udiDi>06945429026511</udiDi>
    <basicUdiDi>B-06945429026511</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:37.512Z</lastUpdated>
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  <row>
    <udiDi>06945429026504</udiDi>
    <basicUdiDi>B-06945429026504</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Low value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:36.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429026498</udiDi>
    <basicUdiDi>B-06945429026498</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Low value:6560-ER00001 Normal value:6560-ER00002 High value:6560-ER00003</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:20:30.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941377305852</udiDi>
    <basicUdiDi>B-06941377305852</basicUdiDi>
    <tradeName>HbA1c Calibrator</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0106-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-25T04:18:04.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415993269</udiDi>
    <basicUdiDi>69449040AB70000063U</basicUdiDi>
    <tradeName>SC-CAL PLUS Hematology Calibrator</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004091-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:40:07.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992927</udiDi>
    <basicUdiDi>69449040AB70000063U</basicUdiDi>
    <tradeName>SC-CAL PLUS Hematology Calibrator</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-003223-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:39:43.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992125</udiDi>
    <basicUdiDi>B-06936415992125</basicUdiDi>
    <tradeName>S50 Calibrator</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-84526</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:39:12.758Z</lastUpdated>
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  <row>
    <udiDi>06936415992118</udiDi>
    <basicUdiDi>B-06936415992118</basicUdiDi>
    <tradeName>S50 Calibrator</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-84525</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:39:11.561Z</lastUpdated>
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  <row>
    <udiDi>06936415992101</udiDi>
    <basicUdiDi>B-06936415992101</basicUdiDi>
    <tradeName>S30 CALIBRATOR</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-60733</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:39:09.171Z</lastUpdated>
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  <row>
    <udiDi>06936415992095</udiDi>
    <basicUdiDi>B-06936415992095</basicUdiDi>
    <tradeName>S30 CALIBRATOR</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 Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-60732</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:39:07.962Z</lastUpdated>
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  <row>
    <udiDi>06935740749565</udiDi>
    <basicUdiDi>69357407IBHS000026EE</basicUdiDi>
    <tradeName>URIT CA 11 Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:05:37.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935740749558</udiDi>
    <basicUdiDi>69357407IBHS000026EE</basicUdiDi>
    <tradeName>URIT CA 11 Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:05:36.360Z</lastUpdated>
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  <row>
    <udiDi>06935740743518</udiDi>
    <basicUdiDi>69357407IBHS000026EE</basicUdiDi>
    <tradeName>URIT CA 11 Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:05:21.954Z</lastUpdated>
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