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    <basicUdiDi>69357407IUCS000008R2</basicUdiDi>
    <tradeName>Quality Control Solution for Urine Analyzer</tradeName>
    <deviceName>Quality Control Solution for Urine Analyzer</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USUD00000285</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:36.985Z</lastUpdated>
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    <udiDi>06935740750226</udiDi>
    <basicUdiDi>69357407IUCS000006QW</basicUdiDi>
    <tradeName>Calibrator Solution for Urine Analyzer</tradeName>
    <deviceName>Calibrator Solution for Urine Analyzer</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>W010106020602</emdnCode>
    <emdnDescription>URINE TESTING CALIBRATORS AND STANDARDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USUC00001088</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:36.295Z</lastUpdated>
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    <udiDi>06935740750172</udiDi>
    <basicUdiDi>69357407IUCS000005QU</basicUdiDi>
    <tradeName>Quality Control Solution for Urine Analyzer</tradeName>
    <deviceName>Quality Control Solution for Urine Analyzer</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>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>USUC00001102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:34.586Z</lastUpdated>
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    <udiDi>06935740749299</udiDi>
    <basicUdiDi>69357407IMP000001YY</basicUdiDi>
    <tradeName>06935740749299</tradeName>
    <deviceName>Slide Maker and Stainer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202059002</emdnCode>
    <emdnDescription>AUTOMATED SLIDE STAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:33.790Z</lastUpdated>
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    <udiDi>06935740744324</udiDi>
    <basicUdiDi>69357407ICAS000044B2</basicUdiDi>
    <tradeName>06935740744324</tradeName>
    <deviceName>Neutral Detergent for Chemistry Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:32.989Z</lastUpdated>
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    <udiDi>06935740744300</udiDi>
    <basicUdiDi>69357407ICAS000043AY</basicUdiDi>
    <tradeName>06935740744300</tradeName>
    <deviceName>Acid Detergent for Chemistry Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:32.183Z</lastUpdated>
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    <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>06935740743440</udiDi>
    <basicUdiDi>69357407IBHS000027EG</basicUdiDi>
    <tradeName>URIT QC 31 Reticulocyte Control</tradeName>
    <deviceName>Reticulocyte Control</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>W0103010506</emdnCode>
    <emdnDescription>RETICULOCYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:30.580Z</lastUpdated>
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    <udiDi>06935740743426</udiDi>
    <basicUdiDi>69357407IBHS000025EC</basicUdiDi>
    <tradeName>URIT QC 11 Hematology Control</tradeName>
    <deviceName>Hematology Control</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>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:29.781Z</lastUpdated>
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  <row>
    <udiDi>06935740743242</udiDi>
    <basicUdiDi>69357407IBHS000035EF</basicUdiDi>
    <tradeName>URIT HQ 51 Hematology Control</tradeName>
    <deviceName>Hematology Control</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>W0103010501</emdnCode>
    <emdnDescription>NORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:28.982Z</lastUpdated>
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    <udiDi>06935740741859</udiDi>
    <basicUdiDi>69357407IBHS000033EB</basicUdiDi>
    <tradeName>URIT 5L 31 Lyse</tradeName>
    <deviceName>Lyse</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:28.168Z</lastUpdated>
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    <udiDi>06935740739597</udiDi>
    <basicUdiDi>69357407ICAS000040AS</basicUdiDi>
    <tradeName>06935740739597</tradeName>
    <deviceName>ISE Quality Control Material</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>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:27.396Z</lastUpdated>
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    <udiDi>06935740739573</udiDi>
    <basicUdiDi>69357407ICAS000042AW</basicUdiDi>
    <tradeName>06935740739573</tradeName>
    <deviceName>Detergent for Electrolyte Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:26.582Z</lastUpdated>
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    <udiDi>06935740739542</udiDi>
    <basicUdiDi>69357407ICAS000039B9</basicUdiDi>
    <tradeName>06935740739542</tradeName>
    <deviceName>Assay Kit for Electrolytes Analysers (Ion-selective Electrode Method)</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>W01010403</emdnCode>
    <emdnDescription>MULTIPLE ELECTROLYTES ONLY - CLIN. CHEM LAB R.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:25.841Z</lastUpdated>
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    <udiDi>06935740735360</udiDi>
    <basicUdiDi>69357407IUD000002XE</basicUdiDi>
    <tradeName>06935740735360</tradeName>
    <deviceName>LaserVision Urine Sediment Analyzer</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>W0201010202</emdnCode>
    <emdnDescription>URINARY SEDIMENT DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:24.982Z</lastUpdated>
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    <udiDi>06935740734004</udiDi>
    <basicUdiDi>69357407IIA000001NM</basicUdiDi>
    <tradeName>06935740734004</tradeName>
    <deviceName>Chemiluminescence Immunoassay Analyzer</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 A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:24.186Z</lastUpdated>
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    <udiDi>06935740733717</udiDi>
    <basicUdiDi>69357407ICAS000036B3</basicUdiDi>
    <tradeName>06935740733717</tradeName>
    <deviceName>Multiple compound quality control products for biochemical immunity</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:23.378Z</lastUpdated>
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    <udiDi>06935740733694</udiDi>
    <basicUdiDi>69357407ICAS000034AX</basicUdiDi>
    <tradeName>06935740733694</tradeName>
    <deviceName>Multiple biochemical calibrators</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>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:22.591Z</lastUpdated>
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    <udiDi>06935740733496</udiDi>
    <basicUdiDi>69357407ICAS000038B7</basicUdiDi>
    <tradeName>06935740733496</tradeName>
    <deviceName>Apolipoprotein B (Apo B) Reagent Kit (Immunoturbidimetric Assay)</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>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:21.797Z</lastUpdated>
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    <udiDi>06935740733441</udiDi>
    <basicUdiDi>69357407ICAS000037B5</basicUdiDi>
    <tradeName>06935740733441</tradeName>
    <deviceName>Apolipoprotein A1 (Apo A1) Assay Kit (Immunoturbidimetric Assay)</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>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:20.981Z</lastUpdated>
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