<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06935784400286</udiDi>
    <basicUdiDi>B-06935784400286</basicUdiDi>
    <tradeName>06935784400286</tradeName>
    <deviceName>Insulin-like Growth Factor Binding Protein-1 &amp; Fetal Fibronectin Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COM-S0101E0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:22.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768011498</udiDi>
    <basicUdiDi>0405686900944W4</basicUdiDi>
    <tradeName>N Antiserum to Human Fibronectin</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_FibNec</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:15.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TD-HNKX-CED-3344</udiDi>
    <basicUdiDi>B-TD-HNKX-CED-3344</basicUdiDi>
    <tradeName>D-TD-HNKX-CED-3344</tradeName>
    <deviceName>Fetal Fibronectin 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:56:33.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD144XJ</udiDi>
    <basicUdiDi>B-GKPD144XJ</basicUdiDi>
    <tradeName>fFN Rapid Test Kit</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD144</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:38:24.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762913</udiDi>
    <basicUdiDi>B-06976202762913</basicUdiDi>
    <tradeName>Fetal Fibronectin (fFN) Rapid Test</tradeName>
    <deviceName>Fetal Fibronectin (fFN) 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHfFN-702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:38:24.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975456580304</udiDi>
    <basicUdiDi>B-06975456580304</basicUdiDi>
    <tradeName>BNIBT</tradeName>
    <deviceName>Fetal Fibronectin (fFN) Rapid Test</deviceName>
    <manufacturerName>Beijing North Institute of Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008259</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RFfFNC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:51:08.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974854621404</udiDi>
    <basicUdiDi>B-06974854621404</basicUdiDi>
    <tradeName>Fetal Fibronectin (fFN) Test</tradeName>
    <deviceName>Fetal Fibronectin (fFN) 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2208625</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:57:00.731Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302745</udiDi>
    <basicUdiDi>B-06974566302745</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50150</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:10.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302738</udiDi>
    <basicUdiDi>B-06974566302738</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50140</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:09.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302721</udiDi>
    <basicUdiDi>B-06974566302721</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50125</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:08.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302714</udiDi>
    <basicUdiDi>B-06974566302714</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50120</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:05.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302707</udiDi>
    <basicUdiDi>B-06974566302707</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50110</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:04.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302691</udiDi>
    <basicUdiDi>B-06974566302691</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-5015</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:03.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302684</udiDi>
    <basicUdiDi>B-06974566302684</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-5013</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:01.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302677</udiDi>
    <basicUdiDi>B-06974566302677</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-5012</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:59.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302660</udiDi>
    <basicUdiDi>B-06974566302660</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-5011</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:57.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302646</udiDi>
    <basicUdiDi>B-06974566302646</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50240</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:56.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302653</udiDi>
    <basicUdiDi>B-06974566302653</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50250</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:55.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302622</udiDi>
    <basicUdiDi>B-06974566302622</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50220</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:52.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566302639</udiDi>
    <basicUdiDi>B-06974566302639</basicUdiDi>
    <tradeName>fFN Rapid Test</tradeName>
    <deviceName>fFN 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>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FFF-50225</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:52:51.327Z</lastUpdated>
  </row>
</eudamedExport>