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    <tradeName>Sharay Insulin (CLIA)</tradeName>
    <deviceName>Sharay Insulin (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18721001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:10.053Z</lastUpdated>
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    <udiDi>06975068490367</udiDi>
    <basicUdiDi>B-06975068490367</basicUdiDi>
    <tradeName>Insulin（INS）Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>Insulin（INS）Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP080.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:30:34.797Z</lastUpdated>
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    <udiDi>06974986814880</udiDi>
    <basicUdiDi>B-06974986814880</basicUdiDi>
    <tradeName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>06974986814873</udiDi>
    <basicUdiDi>B-06974986814873</basicUdiDi>
    <tradeName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:27.950Z</lastUpdated>
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    <udiDi>06974986814866</udiDi>
    <basicUdiDi>B-06974986814866</basicUdiDi>
    <tradeName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin (INS) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:27.265Z</lastUpdated>
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    <udiDi>06974969982162</udiDi>
    <basicUdiDi>B-06974969982162</basicUdiDi>
    <tradeName>Insulin（INS）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin（INS）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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200 Tests/kit（DR1009-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:13:24.663Z</lastUpdated>
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    <udiDi>06974969981592</udiDi>
    <basicUdiDi>B-06974969981592</basicUdiDi>
    <tradeName>Insulin（INS）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin（INS）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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/kit（DR1009-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:11:27.702Z</lastUpdated>
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    <udiDi>06974969981028</udiDi>
    <basicUdiDi>B-06974969981028</basicUdiDi>
    <tradeName>Insulin（INS）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Insulin（INS）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>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/kit（DR1009-1）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:09:29.904Z</lastUpdated>
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    <udiDi>06974854621305</udiDi>
    <basicUdiDi>B-06974854621305</basicUdiDi>
    <tradeName>Insulin (INS) Test</tradeName>
    <deviceName>Insulin (INS) Test</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2210725</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:45.513Z</lastUpdated>
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    <udiDi>06974738205027</udiDi>
    <basicUdiDi>B-06974738205027</basicUdiDi>
    <tradeName>Insulin Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF09-01-40</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:37:52.787Z</lastUpdated>
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    <udiDi>06974738205010</udiDi>
    <basicUdiDi>B-06974738205010</basicUdiDi>
    <tradeName>Insulin Rapid Test Kit (Fluorescence Immunochromatographic Assay)</tradeName>
    <deviceName>Fluorescence Immunochromatography Analyzer</deviceName>
    <manufacturerName>Hoyotek Biomedical Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003570</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IF09-01-20</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:37:48.769Z</lastUpdated>
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    <udiDi>06974674893050</udiDi>
    <basicUdiDi>B-06974674893050</basicUdiDi>
    <tradeName>Insulin (INS) Detection Kit(CLIA)</tradeName>
    <deviceName>Insulin (INS) Detection Kit(CLIA)</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0177</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:18:04.765Z</lastUpdated>
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    <udiDi>06974674892312</udiDi>
    <basicUdiDi>B-06974674892312</basicUdiDi>
    <tradeName>Insulin FIA Kit</tradeName>
    <deviceName>Insulin FIA Kit</deviceName>
    <manufacturerName>Shenzhen Zijian Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000022829</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-02-0061</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:14:07.349Z</lastUpdated>
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    <udiDi>06974671101387</udiDi>
    <basicUdiDi>B-06974671101387</basicUdiDi>
    <tradeName>06974671101387</tradeName>
    <deviceName>Human-Insulin (hInsulin) Quantitative Diagnostic Kit (TRFIA)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-IC-A001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:08:51.329Z</lastUpdated>
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    <udiDi>06974524060663</udiDi>
    <basicUdiDi>B-06974524060663</basicUdiDi>
    <tradeName>Insulin Test Kit (Homogeneous Chemiluminescence Immunoassay)</tradeName>
    <deviceName>Insulin Test Kit (Homogeneous Chemiluminescence Immunoassay)</deviceName>
    <manufacturerName>Nanjing Poclight Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000039609</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCLIA15134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:48:57.219Z</lastUpdated>
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    <udiDi>06974521001546</udiDi>
    <basicUdiDi>B-06974521001546</basicUdiDi>
    <tradeName>INS Assay kit CLIA</tradeName>
    <deviceName>INS Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM083072</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:51.421Z</lastUpdated>
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    <udiDi>06974521001539</udiDi>
    <basicUdiDi>B-06974521001539</basicUdiDi>
    <tradeName>INS Assay kit CLIA</tradeName>
    <deviceName>INS Assay kit CLIA</deviceName>
    <manufacturerName>Shenzhen Superbio Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024149</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUPM083036</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:30:32.956Z</lastUpdated>
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    <basicUdiDi>B-06973861683986</basicUdiDi>
    <tradeName>INS Rapid Test Kit</tradeName>
    <deviceName>INS Rapid Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02078002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:42:53.482Z</lastUpdated>
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    <basicUdiDi>B-06973841001113</basicUdiDi>
    <tradeName>Insulin Test Kit (Immunofluorescence)</tradeName>
    <deviceName>Insulin Test Kit (Immunofluorescence)</deviceName>
    <manufacturerName>Guangdong Wesail Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008828</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA0320</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:39:23.250Z</lastUpdated>
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    <basicUdiDi>B-06972719605149</basicUdiDi>
    <tradeName>06972719605149</tradeName>
    <deviceName>Insulin Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060103</emdnCode>
    <emdnDescription>INSULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:48:56.757Z</lastUpdated>
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