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<eudamedExport entity="devices">
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    <udiDi>06975984062587</udiDi>
    <basicUdiDi>69703416803205052JE</basicUdiDi>
    <tradeName>Cancer Antigen 72-4 (eCLIA)</tradeName>
    <deviceName>Cancer Antigen 72-4 (eCLIA)</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320501701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:01.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942359549394</udiDi>
    <basicUdiDi>697015090000015GV</basicUdiDi>
    <tradeName>CA72-4 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB1403</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:03:54.094Z</lastUpdated>
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  <row>
    <udiDi>06942359517119</udiDi>
    <basicUdiDi>697015090000015GV</basicUdiDi>
    <tradeName>CA72-4 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMB1407</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:48:15.166Z</lastUpdated>
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  <row>
    <udiDi>06944904091112</udiDi>
    <basicUdiDi>69449040004L-CA72-4****PX</basicUdiDi>
    <tradeName>Cancer Antigen 72-4(CLIA)</tradeName>
    <deviceName>Cancer Antigen 72-4(CLIA)、CA72-4 Calibrators</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-005668-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:54:35.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912719335</udiDi>
    <basicUdiDi>692591270162HC</basicUdiDi>
    <tradeName>iFlash-CA72-4</tradeName>
    <deviceName>iFlash-CA72-4</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86070</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:35:13.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20015Z7</udiDi>
    <basicUdiDi>B-R20015Z7</basicUdiDi>
    <tradeName>D-R20015Z7</tradeName>
    <deviceName>Cancer Antigen 72-4 (CA72-4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:08.068Z</lastUpdated>
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  <row>
    <udiDi>D-R20014Z5</udiDi>
    <basicUdiDi>B-R20014Z5</basicUdiDi>
    <tradeName>D-R20014Z5</tradeName>
    <deviceName>Cancer Antigen 72-4 (CA72-4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:07.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20013Z3</udiDi>
    <basicUdiDi>B-R20013Z3</basicUdiDi>
    <tradeName>D-R20013Z3</tradeName>
    <deviceName>Cancer Antigen 72-4 (CA72-4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:06.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20012YZ</udiDi>
    <basicUdiDi>B-R20012YZ</basicUdiDi>
    <tradeName>D-R20012YZ</tradeName>
    <deviceName>Cancer Antigen 72-4 (CA72-4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20012</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:05.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R20011YX</udiDi>
    <basicUdiDi>B-R20011YX</basicUdiDi>
    <tradeName>D-R20011YX</tradeName>
    <deviceName>Cancer Antigen 72-4 (CA72-4) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:08:02.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-6-76AT</udiDi>
    <basicUdiDi>B-6-76AT</basicUdiDi>
    <tradeName>D-6-76AT</tradeName>
    <deviceName>Cancer Antigen 72-4 (CA72-4) Assay Kit (Chemiluminescent Microparticle Immunoassay)</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>"REF: USIA00000135M, USIA00000136M"</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:14:09.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEK004DE</udiDi>
    <basicUdiDi>B-SEK004DE</basicUdiDi>
    <tradeName>CA72-4 Assay Kit (ECLIA)</tradeName>
    <deviceName>CA72-4 Assay Kit (ECLIA)</deviceName>
    <manufacturerName>Jiangsu Sunlant Bioengineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025940</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:32.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-CA72-4-01100C7M</udiDi>
    <basicUdiDi>B-KR-CA72-4-01100C7M</basicUdiDi>
    <tradeName>INNODX CA72-4 CMIA</tradeName>
    <deviceName>INNODX CA72-4 CMIA</deviceName>
    <manufacturerName>Xiamen Innodx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041071</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-CA72-4-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:22.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4407113JF</udiDi>
    <basicUdiDi>B-IM4407113JF</basicUdiDi>
    <tradeName>D-IM4407113JF</tradeName>
    <deviceName>CA 72-4 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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4407113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:28:24.672Z</lastUpdated>
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  <row>
    <udiDi>D-IM4406113J8</udiDi>
    <basicUdiDi>B-IM4406113J8</basicUdiDi>
    <tradeName>D-IM4406113J8</tradeName>
    <deviceName>CA 72-4 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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4406113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:26:19.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IM4403113HK</udiDi>
    <basicUdiDi>B-IM4403113HK</basicUdiDi>
    <tradeName>D-IM4403113HK</tradeName>
    <deviceName>CA 72-4 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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4403113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:22:07.105Z</lastUpdated>
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  <row>
    <udiDi>D-IM4402113HC</udiDi>
    <basicUdiDi>B-IM4402113HC</basicUdiDi>
    <tradeName>D-IM4402113HC</tradeName>
    <deviceName>CA 72-4 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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM4402113</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:17:42.691Z</lastUpdated>
  </row>
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    <udiDi>D-DC76530FV</udiDi>
    <basicUdiDi>B-DC76530FV</basicUdiDi>
    <tradeName>iStar-CA72-4</tradeName>
    <deviceName>iStar-CA72-4</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76530</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:07.829Z</lastUpdated>
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  <row>
    <udiDi>D-DC76531FX</udiDi>
    <basicUdiDi>B-DC76531FX</basicUdiDi>
    <tradeName>iStar-CA72-4</tradeName>
    <deviceName>iStar-CA72-4</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76531</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:05.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76529GC</udiDi>
    <basicUdiDi>B-DC76529GC</basicUdiDi>
    <tradeName>iStar-CA72-4</tradeName>
    <deviceName>iStar-CA72-4</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>W0102030105</emdnCode>
    <emdnDescription>CANCER ANTIGEN 72-4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76529</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:51.660Z</lastUpdated>
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</eudamedExport>