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    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:14.654Z</lastUpdated>
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    <tradeName>IGFBP-3 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>
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    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CML0303</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:51:17.526Z</lastUpdated>
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    <udiDi>06925912720539</udiDi>
    <basicUdiDi>692591270271HJ</basicUdiDi>
    <tradeName>iFlash-IGFBP-3</tradeName>
    <deviceName>iFlash-IGFBP-3</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>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86127</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:19.170Z</lastUpdated>
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    <udiDi>15099590211554</udiDi>
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    <tradeName>ACTIVE® IGFBP-3 IRMA</tradeName>
    <deviceName>ACTIVE® IGFBP-3 IRMA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL6600</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:43:08.696Z</lastUpdated>
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    <udiDi>00630414966113</udiDi>
    <basicUdiDi>0405686901389W3</basicUdiDi>
    <tradeName>IMMULITE 2000 IGFBP-3</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_B_REAG_KIT_IGFBP-3</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10381447</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T06:09:52.517Z</lastUpdated>
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    <udiDi>D-TD-HNKX-CED-403Z</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-403Z</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-403Z</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein 3 Kit (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>Hunan Kangxin Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020121</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:45.020Z</lastUpdated>
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    <udiDi>D-DC76505FW</udiDi>
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    <tradeName>iStar-IGFBP-3</tradeName>
    <deviceName>iStar-IGFBP-3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76505</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:11.372Z</lastUpdated>
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    <tradeName>iStar-IGFBP-3</tradeName>
    <deviceName>iStar-IGFBP-3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76504</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:08.973Z</lastUpdated>
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    <udiDi>D-DC76503FS</udiDi>
    <basicUdiDi>B-DC76503FS</basicUdiDi>
    <tradeName>iStar-IGFBP-3</tradeName>
    <deviceName>iStar-IGFBP-3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76503</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:04.281Z</lastUpdated>
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    <udiDi>D-DC76080FK</udiDi>
    <basicUdiDi>B-DC76080FK</basicUdiDi>
    <tradeName>iStar-IGFBP-3</tradeName>
    <deviceName>iStar-IGFBP-3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:04:18.553Z</lastUpdated>
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  <row>
    <udiDi>D-7F07E7</udiDi>
    <basicUdiDi>B-7F07E7</basicUdiDi>
    <tradeName>IGFBP-3 assay (CLIA)</tradeName>
    <deviceName>IGFBP-3 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7F07V1-B-EU, 7F07U1-B-EU, 7F07P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:28:18.242Z</lastUpdated>
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    <udiDi>06925912720546</udiDi>
    <basicUdiDi>692591270271HJ</basicUdiDi>
    <tradeName>iFlash-IGFBP-3</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>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86127-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:11.555Z</lastUpdated>
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    <udiDi>06975984064079</udiDi>
    <basicUdiDi>69703416803205106JC</basicUdiDi>
    <tradeName>IGFBP-3 (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:53:35.848Z</lastUpdated>
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    <udiDi>06942359551618</udiDi>
    <basicUdiDi>697015090000263HJ</basicUdiDi>
    <tradeName>IGFBP-3 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>UNKNOWN</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CML0305</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:38:12.494Z</lastUpdated>
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    <udiDi>06975984064086</udiDi>
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    <tradeName>IGFBP-3 (eCLIA)</tradeName>
    <deviceName>IGFBP-3 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:21:03.962Z</lastUpdated>
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    <udiDi>06975984064062</udiDi>
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    <tradeName>IGFBP-3 (eCLIA)</tradeName>
    <deviceName>IGFBP-3 (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320509502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:20:56.285Z</lastUpdated>
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    <udiDi>06972719604883</udiDi>
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    <tradeName>06972719604883</tradeName>
    <deviceName>Insulin-Like Growth Factor Binding Protein-3 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>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:48:00.670Z</lastUpdated>
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    <deviceName>Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:47:59.849Z</lastUpdated>
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    <deviceName>Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:40:00.863Z</lastUpdated>
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    <tradeName>06972719602513</tradeName>
    <deviceName>Insulin-Like Growth Factor Binding Protein-3 Chemiluminescence Immunoassay Kit</deviceName>
    <manufacturerName>Nanjing RealMind Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024838</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0102060406</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50tests/kit</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T12:39:59.262Z</lastUpdated>
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