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<eudamedExport entity="devices">
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    <basicUdiDi>697846523HormoneC01HU</basicUdiDi>
    <tradeName>cortisol Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>cortisol Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:03.592Z</lastUpdated>
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    <udiDi>06978465236002</udiDi>
    <basicUdiDi>697846523HormoneC01HU</basicUdiDi>
    <tradeName>cortisol Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>cortisol Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:02.402Z</lastUpdated>
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    <udiDi>06970664752017</udiDi>
    <basicUdiDi>B-06970664752017</basicUdiDi>
    <tradeName>06970664752017</tradeName>
    <deviceName>Neutrophil Gelatinase Associated Lipocalin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:33:37.366Z</lastUpdated>
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    <udiDi>06970664751997</udiDi>
    <basicUdiDi>B-06970664751997</basicUdiDi>
    <tradeName>06970664751997</tradeName>
    <deviceName>Kidney Injury Molecule 1 Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>BEIJING KEWEI CLINICAL DIAGNOSTIC REAGENT INC</manufacturerName>
    <manufacturerSrn>CN-MF-000019125</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060299</emdnCode>
    <emdnDescription>RENAL METABOLISM TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25Tests/Kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:33:36.160Z</lastUpdated>
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    <udiDi>06970150908539</udiDi>
    <basicUdiDi>697015090000021GQ</basicUdiDi>
    <tradeName>Renin CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMD0402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:47:47.150Z</lastUpdated>
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    <udiDi>06970150908522</udiDi>
    <basicUdiDi>697015090000020GN</basicUdiDi>
    <tradeName>Cortisol CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMD0302</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:47:45.951Z</lastUpdated>
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    <udiDi>06970150906191</udiDi>
    <basicUdiDi>697015090000021GQ</basicUdiDi>
    <tradeName>Renin CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMD0401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:46:00.275Z</lastUpdated>
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    <udiDi>06970150906177</udiDi>
    <basicUdiDi>697015090000020GN</basicUdiDi>
    <tradeName>Cortisol CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMD0304</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:45:59.078Z</lastUpdated>
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    <udiDi>06970150906153</udiDi>
    <basicUdiDi>697015090000020GN</basicUdiDi>
    <tradeName>Cortisol CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMD0301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-29T19:45:53.079Z</lastUpdated>
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    <udiDi>06903053061995</udiDi>
    <basicUdiDi>69449040AB74000085L</basicUdiDi>
    <tradeName>Aldosterone (CLIA)</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>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-031481-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:30.006Z</lastUpdated>
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  <row>
    <udiDi>06903053093781</udiDi>
    <basicUdiDi>69449040AB74000715T</basicUdiDi>
    <tradeName>Angiotensin Ⅱ(CLIA)</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-049532-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:10:49.202Z</lastUpdated>
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    <udiDi>06903053093835</udiDi>
    <basicUdiDi>69449040AB740006968</basicUdiDi>
    <tradeName>AngiotensinⅠ(CLIA)</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-049534-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:10:49.161Z</lastUpdated>
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  <row>
    <udiDi>06903053098151</udiDi>
    <basicUdiDi>69449040AB740006968</basicUdiDi>
    <tradeName>AI Calibrators</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-051447-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:10:48.257Z</lastUpdated>
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    <udiDi>06903053098168</udiDi>
    <basicUdiDi>69449040AB74000715T</basicUdiDi>
    <tradeName>AII Calibrators</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>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-051448-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:10:48.234Z</lastUpdated>
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    <udiDi>06903053158305</udiDi>
    <basicUdiDi>69449040004L-Cortisol**MW</basicUdiDi>
    <tradeName>Cortisol(CLIA)</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060203</emdnCode>
    <emdnDescription>CORTISOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-064666-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:10:12.871Z</lastUpdated>
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    <udiDi>06954414798883</udiDi>
    <basicUdiDi>B-06954414798883</basicUdiDi>
    <tradeName>Getein</tradeName>
    <deviceName>MAGICL Angiotensin II (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:34:51.758Z</lastUpdated>
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    <udiDi>06954414798876</udiDi>
    <basicUdiDi>B-06954414798876</basicUdiDi>
    <tradeName>Getein</tradeName>
    <deviceName>MAGICL Angiotensin I (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060202</emdnCode>
    <emdnDescription>ANGIOTENSIN I / II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:34:45.742Z</lastUpdated>
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    <udiDi>06954414798654</udiDi>
    <basicUdiDi>B-06954414798654</basicUdiDi>
    <tradeName>MAGICL NGAL (CLIA)</tradeName>
    <deviceName>MAGICL NGAL (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060207</emdnCode>
    <emdnDescription>NEUTROPHIL GELATINASE ASSOCIATED LIPOCALIN (LIPOCALIN 2)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:34:17.405Z</lastUpdated>
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    <udiDi>06954414798579</udiDi>
    <basicUdiDi>B-06954414798579</basicUdiDi>
    <tradeName>MAGICL Renin (CLIA)</tradeName>
    <deviceName>MAGICL Renin (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060204</emdnCode>
    <emdnDescription>RENINE (PLASMA RENINE ACTIVITY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:57.702Z</lastUpdated>
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    <udiDi>06954414798531</udiDi>
    <basicUdiDi>B-06954414798531</basicUdiDi>
    <tradeName>Getein</tradeName>
    <deviceName>MAGICL ALD (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060201</emdnCode>
    <emdnDescription>ALDOSTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:33:48.102Z</lastUpdated>
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