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    <tradeName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</tradeName>
    <deviceName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHD200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:19.931Z</lastUpdated>
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    <basicUdiDi>B-06977125152409</basicUdiDi>
    <tradeName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</tradeName>
    <deviceName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T22:11:19.112Z</lastUpdated>
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    <deviceName>iMOST-U Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UQ001010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:27.717Z</lastUpdated>
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    <basicUdiDi>B-06976894950209</basicUdiDi>
    <tradeName>06976894950209</tradeName>
    <deviceName>iMOST-U Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UQ001025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:26.919Z</lastUpdated>
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    <basicUdiDi>B-06976894950179</basicUdiDi>
    <tradeName>06976894950179</tradeName>
    <deviceName>iMOST-U Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UQ001050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:26.118Z</lastUpdated>
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    <basicUdiDi>B-06976894950148</basicUdiDi>
    <tradeName>06976894950148</tradeName>
    <deviceName>iMOST-U Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UQ001100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:22.127Z</lastUpdated>
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    <basicUdiDi>B-06976894950117</basicUdiDi>
    <tradeName>06976894950117</tradeName>
    <deviceName>iMOST-L Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LQ001010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:21.312Z</lastUpdated>
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    <tradeName>06976894950087</tradeName>
    <deviceName>iMOST-L Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LQ001025</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:20.524Z</lastUpdated>
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    <basicUdiDi>B-06976894950056</basicUdiDi>
    <tradeName>06976894950056</tradeName>
    <deviceName>iMOST-L Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LQ001050</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:19.722Z</lastUpdated>
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    <basicUdiDi>B-06976894950025</basicUdiDi>
    <tradeName>06976894950025</tradeName>
    <deviceName>iMOST-L Hematology Q-card</deviceName>
    <manufacturerName>Essenlix Biotechnology (Shanghai) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000038839</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010699</emdnCode>
    <emdnDescription>HAEMATOLOGY RAPID TESTS &amp; POINT OF CARE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LQ001100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:02:15.707Z</lastUpdated>
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    <udiDi>06976578180656</udiDi>
    <basicUdiDi>B-06976578180656</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-3D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900209</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:39.466Z</lastUpdated>
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    <basicUdiDi>B-06976578180649</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-3D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:38.662Z</lastUpdated>
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    <basicUdiDi>B-06976578180632</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-5D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:34.672Z</lastUpdated>
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    <basicUdiDi>B-06976578180625</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-5D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:33.859Z</lastUpdated>
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    <basicUdiDi>B-06976578180618</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-5D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900214</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:33.060Z</lastUpdated>
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    <basicUdiDi>B-06976578180601</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-3D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:32.253Z</lastUpdated>
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    <basicUdiDi>B-06976578180083</basicUdiDi>
    <tradeName>Hematology Calibrator</tradeName>
    <deviceName>Hematology Calibrator</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900302</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:26.766Z</lastUpdated>
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    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-3D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:26.286Z</lastUpdated>
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    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control L-5D</deviceName>
    <manufacturerName>Wheisman Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045463</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320900211</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:53:21.919Z</lastUpdated>
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    <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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