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<eudamedExport entity="devices">
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    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0008-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:07.254Z</lastUpdated>
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  <row>
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    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0006-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:03.206Z</lastUpdated>
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    <udiDi>06903053011297</udiDi>
    <basicUdiDi>69449040XQSJ-003F******7Y</basicUdiDi>
    <tradeName>S50 Calibrator</tradeName>
    <deviceName>BR60 Hematology Control，SC-CAL RET Hematology Calibrator</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>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-026332-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:56:38.276Z</lastUpdated>
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  <row>
    <udiDi>06903053029070</udiDi>
    <basicUdiDi>69449040AB70000143T</basicUdiDi>
    <tradeName>SC-CAL RET Hematology Calibrator</tradeName>
    <deviceName>SC-CAL RET Hematology Calibrator、BR60 Hematology Contro</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>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-018565-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:48:24.369Z</lastUpdated>
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  <row>
    <udiDi>05999106200207</udiDi>
    <basicUdiDi>59991062NormaCalZ8</basicUdiDi>
    <tradeName>NormaCal3 calibrator for Norma hematology analyzers</tradeName>
    <deviceName>NormaCal3 calibrator for Norma hematology analyzers</deviceName>
    <manufacturerName>NORMA Instruments Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000014244</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NIC-CAL32</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:35:52.152Z</lastUpdated>
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  <row>
    <udiDi>03610230008577</udiDi>
    <basicUdiDi>361023minocalJC</basicUdiDi>
    <tradeName>ABX Minocal</tradeName>
    <deviceName>ABX Minocal</deviceName>
    <manufacturerName>HORIBA ABX SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000000320</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>1212032002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:12:44.693Z</lastUpdated>
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    <tradeName>COULTER</tradeName>
    <deviceName>COULTER S-CAL Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>628026</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:35:25.399Z</lastUpdated>
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  <row>
    <udiDi>06978066777089</udiDi>
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    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>6530-PA00004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:00:23.623Z</lastUpdated>
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  <row>
    <udiDi>00630414600826</udiDi>
    <basicUdiDi>0405686901679WF</basicUdiDi>
    <tradeName>ADVIA 360/560 Calibrator</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Calibrator</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11170852</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:55.419Z</lastUpdated>
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  <row>
    <udiDi>00630414224343</udiDi>
    <basicUdiDi>0405686900797WF</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i SETpoint Calibrator</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_SETpoint Calibrator</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10312285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:39.333Z</lastUpdated>
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  <row>
    <udiDi>00630414224329</udiDi>
    <basicUdiDi>0405686900791W3</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i OPTIpoint</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_OPTIpoint</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10312283</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:34.523Z</lastUpdated>
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  <row>
    <udiDi>06978066777065</udiDi>
    <basicUdiDi>697806677HE001JV</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>6530-PA00002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:18.025Z</lastUpdated>
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  <row>
    <udiDi>06978066777072</udiDi>
    <basicUdiDi>697806677HE001JV</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen CoooSeee Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045646</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>6530-PA00003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:46:00.586Z</lastUpdated>
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  <row>
    <udiDi>D-628026Q5</udiDi>
    <basicUdiDi>B-628026Q5</basicUdiDi>
    <tradeName>S-CAL Calibrator</tradeName>
    <deviceName>S-CAL Calibrator</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>628026</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:39:04.976Z</lastUpdated>
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    <udiDi>D-624519Q5</udiDi>
    <basicUdiDi>B-624519Q5</basicUdiDi>
    <tradeName>COULTER S-CAL Calibrator Kit</tradeName>
    <deviceName>COULTER S-CAL Calibrator Kit</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>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>624519</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:38.724Z</lastUpdated>
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    <basicUdiDi>0815762028CPC3</basicUdiDi>
    <tradeName>CBC-CAL PLUS</tradeName>
    <deviceName>NCAL1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:38.022Z</lastUpdated>
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    <basicUdiDi>0815762020CT02A</basicUdiDi>
    <tradeName>Tech-Cal</tradeName>
    <deviceName>Tech-Cal</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
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    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0CT010TA3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:37.207Z</lastUpdated>
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    <tradeName>Tech-Cal</tradeName>
    <deviceName>Tech-Cal</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCV11</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:21:02.580Z</lastUpdated>
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    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE003</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:20:46.809Z</lastUpdated>
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    <udiDi>D-QS2102-02PL</udiDi>
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    <tradeName>D-QS2102-02PL</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:15.282Z</lastUpdated>
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