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    <tradeName>iFlash-Renin</tradeName>
    <deviceName>iFlash-Renin</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86284</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:45.542Z</lastUpdated>
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    <udiDi>08056771100595</udiDi>
    <basicUdiDi>B-08056771100595</basicUdiDi>
    <tradeName>LIAISON® Direct Renin</tradeName>
    <deviceName>LIAISON® Direct Renin</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <reference>310470</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>D-Renin706-AEQY</udiDi>
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    <tradeName>Renin (CLIA)</tradeName>
    <deviceName>Renin (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:33:30.971Z</lastUpdated>
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    <udiDi>D-IM4407456KG</udiDi>
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    <tradeName>D-IM4407456KG</tradeName>
    <deviceName>Renin Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407456</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:29:35.959Z</lastUpdated>
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    <udiDi>D-IM4406456K9</udiDi>
    <basicUdiDi>B-IM4406456K9</basicUdiDi>
    <tradeName>D-IM4406456K9</tradeName>
    <deviceName>Renin Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406456</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:27:35.599Z</lastUpdated>
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    <udiDi>D-IM4403456JL</udiDi>
    <basicUdiDi>B-IM4403456JL</basicUdiDi>
    <tradeName>D-IM4403456JL</tradeName>
    <deviceName>Renin Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403456</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:23:25.613Z</lastUpdated>
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    <udiDi>D-IM4402456JD</udiDi>
    <basicUdiDi>B-IM4402456JD</basicUdiDi>
    <tradeName>D-IM4402456JD</tradeName>
    <deviceName>Renin Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402456</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:19:14.068Z</lastUpdated>
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    <udiDi>06925912721581</udiDi>
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    <tradeName>iFlash-Renin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86284-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.340Z</lastUpdated>
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    <udiDi>06974969982599</udiDi>
    <basicUdiDi>B-06974969982599</basicUdiDi>
    <tradeName>Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1117-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:16:28.066Z</lastUpdated>
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    <udiDi>06974969982025</udiDi>
    <basicUdiDi>B-06974969982025</basicUdiDi>
    <tradeName>Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1117-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:13:01.447Z</lastUpdated>
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    <udiDi>06974969981455</udiDi>
    <basicUdiDi>B-06974969981455</basicUdiDi>
    <tradeName>Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</tradeName>
    <deviceName>Renin Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay）</deviceName>
    <manufacturerName>Biobase Diagnostic Technology (Shandong) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025964</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1117-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:11:04.466Z</lastUpdated>
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    <udiDi>03770024321319</udiDi>
    <basicUdiDi>B-03770024321319</basicUdiDi>
    <tradeName>RENINE III GENERATION</tradeName>
    <deviceName>RENINE</deviceName>
    <manufacturerName>Cisbio Bioassays</manufacturerName>
    <manufacturerSrn>FR-MF-000024051</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RENINE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:31:58.432Z</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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    <tradeName>Renin CLIA Microparticles</tradeName>
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    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <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>06936595751598</udiDi>
    <basicUdiDi>B-06936595751598</basicUdiDi>
    <tradeName>Renin Kit (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060206</emdnCode>
    <emdnDescription>RENINE DIRECT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG1423Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:57:15.124Z</lastUpdated>
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