<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TD-HNKX-CED-394G</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-394G</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-394G</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein 1 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>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:43.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD142XE</udiDi>
    <basicUdiDi>B-GKPD142XE</basicUdiDi>
    <tradeName>IGFBP-1 Rapid Test Kit</tradeName>
    <deviceName>IGFBP-1 Rapid Test Kit</deviceName>
    <manufacturerName>Dezhou Guoke Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044128</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD142</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:22.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAIGF1-502aL2</udiDi>
    <basicUdiDi>B-GAIGF1-502aL2</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test Cassette (Swab)</tradeName>
    <deviceName>iGFBP-1 Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAIGF1-502a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:12:32.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAIGF1-502aHGPY</udiDi>
    <basicUdiDi>B-GAIGF1-502aHGPY</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test Cassette (Swab)</tradeName>
    <deviceName>iGFBP-1 Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAIGF1-502a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:12:28.200Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAIGF1-501aKX</udiDi>
    <basicUdiDi>B-GAIGF1-501aKX</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test Strip (Cervical Secretion)</tradeName>
    <deviceName>iGFBP-1 Rapid Test Strip (Cervical Secretion)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAIGF1-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:12:27.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GAIGF1-501aHGPR</udiDi>
    <basicUdiDi>B-GAIGF1-501aHGPR</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test Strip (Swab)</tradeName>
    <deviceName>iGFBP-1 Rapid Test Strip (Swab)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAIGF1-501a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:12:26.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030578</udiDi>
    <basicUdiDi>B-08684595030578</basicUdiDi>
    <tradeName>RapidFor™  IGFBP-1 Test Kit</tradeName>
    <deviceName>IGFBP-1 Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:14:25.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202763316</udiDi>
    <basicUdiDi>B-06976202763316</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHIGF-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:39:51.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621350</udiDi>
    <basicUdiDi>B-06974854621350</basicUdiDi>
    <tradeName>IGFBP-1 Test</tradeName>
    <deviceName>IGFBP-1 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>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2208125</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:56:52.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302561</udiDi>
    <basicUdiDi>B-06974566302561</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50150</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:29.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302554</udiDi>
    <basicUdiDi>B-06974566302554</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50140</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:27.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302547</udiDi>
    <basicUdiDi>B-06974566302547</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50125</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:25.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302530</udiDi>
    <basicUdiDi>B-06974566302530</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50120</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:24.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302523</udiDi>
    <basicUdiDi>B-06974566302523</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50110</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:23.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302516</udiDi>
    <basicUdiDi>B-06974566302516</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-5013</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:20.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302509</udiDi>
    <basicUdiDi>B-06974566302509</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-5013</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:19.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302493</udiDi>
    <basicUdiDi>B-06974566302493</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-5012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:18.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302486</udiDi>
    <basicUdiDi>B-06974566302486</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-5011</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:16.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302479</udiDi>
    <basicUdiDi>B-06974566302479</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50250</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:14.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302462</udiDi>
    <basicUdiDi>B-06974566302462</basicUdiDi>
    <tradeName>iGFBP-1 Rapid Test</tradeName>
    <deviceName>iGFBP-1 Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIG-50240</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:13.221Z</lastUpdated>
  </row>
</eudamedExport>