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<eudamedExport entity="devices">
  <row>
    <udiDi>D-GKPD181XQ</udiDi>
    <basicUdiDi>B-GKPD181XQ</basicUdiDi>
    <tradeName>Calprotectin Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>Calprotectin Detection Kit (Immunofluorescence Chromatography)</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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD181</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:36.362Z</lastUpdated>
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  <row>
    <udiDi>D-FDCAL-602aQQ</udiDi>
    <basicUdiDi>B-FDCAL-602aQQ</basicUdiDi>
    <tradeName>Calprotectin Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Calprotectin Quantitative Test Kit (Time-Resolved FIA)</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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCAL-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:36.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FDCAL-602aHGLL</udiDi>
    <basicUdiDi>B-FDCAL-602aHGLL</basicUdiDi>
    <tradeName>Calprotectin Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>Calprotectin Quantitative Test Kit (Time-Resolved FIA)</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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDCAL-602a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:19:32.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A008CX</udiDi>
    <basicUdiDi>B-A008CX</basicUdiDi>
    <tradeName>INDICAID™ Calprotectin/Lactoferrin Rapid Test</tradeName>
    <deviceName>INDICAID™ Calprotectin/Lactoferrin Rapid Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Calprotectin/Lactoferrin Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:10.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065023763730</udiDi>
    <basicUdiDi>B-15065023763730</basicUdiDi>
    <tradeName>TruVue</tradeName>
    <deviceName>Calprotectin Test (FIA)</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TV20035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:36:21.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998279734</udiDi>
    <basicUdiDi>B-08684998279734</basicUdiDi>
    <tradeName>RapidFor™ Calprotectin (50µg/g+ 200µg/g) Test Kit</tradeName>
    <deviceName>Calprotectin (50µg/g+ 200µg/g) 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD137</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:04.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684998279727</udiDi>
    <basicUdiDi>B-08684998279727</basicUdiDi>
    <tradeName>RapidFor™ Calprotectin (50µg/g+ 200µg/g) Test Kit</tradeName>
    <deviceName>Calprotectin (50µg/g+ 200µg/g) 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD137</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:22:00.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595039144</udiDi>
    <basicUdiDi>B-08684595039144</basicUdiDi>
    <tradeName>RapidFor™ Calprotectin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Calprotectin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO80GD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:17:39.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595035092</udiDi>
    <basicUdiDi>B-08684595035092</basicUdiDi>
    <tradeName>RapidFor™ Calprotectin (50µg/g+ 200µg/g) Test Kit</tradeName>
    <deviceName>Calprotectin (50µg/g+ 200µg/g) 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD137</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:16:10.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030523</udiDi>
    <basicUdiDi>B-08684595030523</basicUdiDi>
    <tradeName>RapidFor™ Calprotectin Rapid Test Kit</tradeName>
    <deviceName>Calprotectin Rapid 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>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMD115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:14:08.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595030189</udiDi>
    <basicUdiDi>B-08684595030189</basicUdiDi>
    <tradeName>RapidFor™ Calprotectin Rapid Test Kit (FIA)</tradeName>
    <deviceName>Calprotectin Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO80</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:02.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950907206</udiDi>
    <basicUdiDi>B-08426950907206</basicUdiDi>
    <tradeName>QUANTA Flash</tradeName>
    <deviceName>QUANTA Flash® Calprotectin Reagents</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701350</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:22:40.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090028592703</udiDi>
    <basicUdiDi>B-07090028592703</basicUdiDi>
    <tradeName>07090028592703</tradeName>
    <deviceName>Calprolab Calprotectin ELISA (HRP)</deviceName>
    <manufacturerName>Calpro AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALP0270</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:31.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>07090028591706</udiDi>
    <basicUdiDi>B-07090028591706</basicUdiDi>
    <tradeName>07090028591706</tradeName>
    <deviceName>Calprolab Calprotectin ELISA (ALP)</deviceName>
    <manufacturerName>Calpro AS</manufacturerName>
    <manufacturerSrn>NO-MF-000036194</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CALP0170</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:57:16.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416127</udiDi>
    <basicUdiDi>B-06978896416127</basicUdiDi>
    <tradeName>06978896416127</tradeName>
    <deviceName>Fecal Calprotectin (FC) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-FC-40</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:14.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978896416110</udiDi>
    <basicUdiDi>B-06978896416110</basicUdiDi>
    <tradeName>06978896416110</tradeName>
    <deviceName>Fecal Calprotectin (FC) Test Kit (Immunofluorescence Method)</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-IF2-FC-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:50:13.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977568200118</udiDi>
    <basicUdiDi>B-06977568200118</basicUdiDi>
    <tradeName>06977568200118</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×120 Tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:36.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977568200101</udiDi>
    <basicUdiDi>B-06977568200101</basicUdiDi>
    <tradeName>06977568200101</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120 Tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:35.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977568200095</udiDi>
    <basicUdiDi>B-06977568200095</basicUdiDi>
    <tradeName>06977568200095</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1：2×15 mL、R2：2×4.2 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:35.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977568200088</udiDi>
    <basicUdiDi>B-06977568200088</basicUdiDi>
    <tradeName>06977568200088</tradeName>
    <deviceName>Fecal Calprotectin Assay Kit (Latex Immunoturbidimetric Method)</deviceName>
    <manufacturerName>Shenzhen Cavan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000052933</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1：1×15 mL、R2：1×4.2 mL</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:23:31.013Z</lastUpdated>
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</eudamedExport>