<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IM4402110H6</udiDi>
    <basicUdiDi>B-IM4402110H6</basicUdiDi>
    <tradeName>D-IM4402110H6</tradeName>
    <deviceName>CA 50 Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030104</emdnCode>
    <emdnDescription>CANCER ANTIGEN 50</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402110</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:37.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4402109HM</udiDi>
    <basicUdiDi>B-IM4402109HM</basicUdiDi>
    <tradeName>D-IM4402109HM</tradeName>
    <deviceName>CYFRA21-1 Chemiluminescent Immunoassay Kit</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Humiss International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001490</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:36.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HE4706-AEFT</udiDi>
    <basicUdiDi>B-HE4706-AEFT</basicUdiDi>
    <tradeName>HE4 Human Epididymal Protein 4 (CLIA)</tradeName>
    <deviceName>HE4 Human Epididymal Protein 4 (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HE4706-AE10Y, HE4706-AE10N, HE4706-AE20Y, HE4706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:53:43.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD188Y6</udiDi>
    <basicUdiDi>B-GKPD188Y6</basicUdiDi>
    <tradeName>CA125  Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>CA125  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>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD188</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:47.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD187Y4</udiDi>
    <basicUdiDi>B-GKPD187Y4</basicUdiDi>
    <tradeName>CA19-9  Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>CA19-9  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>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD187</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:47.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD186Y2</udiDi>
    <basicUdiDi>B-GKPD186Y2</basicUdiDi>
    <tradeName>CA15-3  Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>CA15-3  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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD186</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:46.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GKPD182XS</udiDi>
    <basicUdiDi>B-GKPD182XS</basicUdiDi>
    <tradeName>CEA Detection Kit (Immunofluorescence Chromatography)</tradeName>
    <deviceName>CEA 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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GKPD182</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:39:40.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GENMP22-102aHGGZ</udiDi>
    <basicUdiDi>B-GENMP22-102aHGGZ</basicUdiDi>
    <tradeName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</tradeName>
    <deviceName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</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>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GENMP22-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:27.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GENMP22-102a47</udiDi>
    <basicUdiDi>B-GENMP22-102a47</basicUdiDi>
    <tradeName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</tradeName>
    <deviceName>One Step Nuclear Matrix Protein 22 Test Cassette (Urine)</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>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GENMP22-102a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:35:26.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GECEA-402aPK</udiDi>
    <basicUdiDi>B-GECEA-402aPK</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Carcinoembryonic Antigen Rapid Test Cassette (Whole Blood/Serum/Plasma)</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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GECEA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:34:38.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GECEA-402aHGJ9</udiDi>
    <basicUdiDi>B-GECEA-402aHGJ9</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen Rapid Test Cassette (Whole  Blood/Serum/Plasma)</tradeName>
    <deviceName>Carcinoembryonic Antigen Rapid Test Cassette (Whole  Blood/Serum/Plasma)</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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GECEA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:34:33.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GECEA-401aPG</udiDi>
    <basicUdiDi>B-GECEA-401aPG</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)</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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GECEA-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:34:33.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GECEA-401aHGJ2</udiDi>
    <basicUdiDi>B-GECEA-401aHGJ2</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Carcinoembryonic Antigen Rapid Test Strip (Whole Blood/Serum/Plasma)</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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GECEA-401a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:34:32.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GEBTA-102aWA</udiDi>
    <basicUdiDi>B-GEBTA-102aWA</basicUdiDi>
    <tradeName>Bladder Tumor Antigen Rapid Test Cassette (Urine)</tradeName>
    <deviceName>Bladder Tumor Antigen Rapid Test Cassette (Urine)</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>W0102030101</emdnCode>
    <emdnDescription>BLADDER TUMOUR ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEBTA-102a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:34:31.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414599816</udiDi>
    <basicUdiDi>0405686901820VQ</basicUdiDi>
    <tradeName>Atellica IM Prostate-Specific Antigen (PSA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995663</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:59:40.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414599809</udiDi>
    <basicUdiDi>0405686901820VQ</basicUdiDi>
    <tradeName>Atellica IM Prostate-Specific Antigen (PSA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995662</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T19:57:11.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FECEA-402aNN</udiDi>
    <basicUdiDi>B-FECEA-402aNN</basicUdiDi>
    <tradeName>CEA Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>CEA 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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FECEA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:26.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FECEA-402aHGH4</udiDi>
    <basicUdiDi>B-FECEA-402aHGH4</basicUdiDi>
    <tradeName>CEA Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FECEA-402a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:26:25.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4407107GL</udiDi>
    <basicUdiDi>B-EIM4407107GL</basicUdiDi>
    <tradeName>D-EIM4407107GL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4407107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:25.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EIM4407106GJ</udiDi>
    <basicUdiDi>B-EIM4407106GJ</basicUdiDi>
    <tradeName>D-EIM4407106GJ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EIM4407106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:58:24.886Z</lastUpdated>
  </row>
</eudamedExport>