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<eudamedExport entity="devices">
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    <udiDi>00630414461311</udiDi>
    <basicUdiDi>0405686901801VL</basicUdiDi>
    <tradeName>ADVIA Centaur® CA 15-3®</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_CA 15-3</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10327620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:34:02.350Z</lastUpdated>
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  <row>
    <udiDi>00630414598130</udiDi>
    <basicUdiDi>0405686901801VL</basicUdiDi>
    <tradeName>Atellica IM CA 15-3 (CA15-3)</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995486</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:57.616Z</lastUpdated>
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  <row>
    <udiDi>00630414598123</udiDi>
    <basicUdiDi>0405686901801VL</basicUdiDi>
    <tradeName>Atellica IM CA 15-3 (CA15-3)</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995485</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:49:57.453Z</lastUpdated>
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  <row>
    <udiDi>D-SEK002DA</udiDi>
    <basicUdiDi>B-SEK002DA</basicUdiDi>
    <tradeName>CA15-3 Assay Kit (ECLIA)</tradeName>
    <deviceName>CA15-3 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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE-K002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:12:31.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-KR-CA15-3-01100C3X</udiDi>
    <basicUdiDi>B-KR-CA15-3-01100C3X</basicUdiDi>
    <tradeName>INNODX CA15-3 CMIA</tradeName>
    <deviceName>INNODX CA15-3 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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KR-CA15-3-01100C</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:42:16.000Z</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>
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  <row>
    <udiDi>D-DC76423FT</udiDi>
    <basicUdiDi>B-DC76423FT</basicUdiDi>
    <tradeName>iStar-CA15-3</tradeName>
    <deviceName>iStar-CA15-3</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76423</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:14:24.987Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76422FR</udiDi>
    <basicUdiDi>B-DC76422FR</basicUdiDi>
    <tradeName>iStar-CA15-3</tradeName>
    <deviceName>iStar-CA15-3</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76422</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:14:24.854Z</lastUpdated>
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  <row>
    <udiDi>D-DC76421FP</udiDi>
    <basicUdiDi>B-DC76421FP</basicUdiDi>
    <tradeName>iStar-CA15-3</tradeName>
    <deviceName>iStar-CA15-3</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76421</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:14:20.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76420FM</udiDi>
    <basicUdiDi>B-DC76420FM</basicUdiDi>
    <tradeName>iStar-CA15-3</tradeName>
    <deviceName>iStar-CA15-3</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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76420</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:14:19.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76040F7</udiDi>
    <basicUdiDi>B-DC76040F7</basicUdiDi>
    <tradeName>iStar-CA15-3</tradeName>
    <deviceName>iStar-CA15-3</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:03:26.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CA15-3706-AEZE</udiDi>
    <basicUdiDi>B-CA15-3706-AEZE</basicUdiDi>
    <tradeName>CA15-3 Cancer Antigen 15-3 (CLIA)</tradeName>
    <deviceName>CA15-3 Cancer Antigen 15-3 (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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA15-3706-AE10Y, CA15-3706-AE10N, CA15-3706-AE20Y, CA15-3706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:55:11.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-7C10DD</udiDi>
    <basicUdiDi>B-7C10DD</basicUdiDi>
    <tradeName>Cancer Antigen 15-3 assay (CLIA)</tradeName>
    <deviceName>Cancer Antigen 15-3 assay (CLIA)</deviceName>
    <manufacturerName>Xiamen Boson Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001096</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>7C10V1-B-EU, 7C10U1-B-EU, 7C10P1-B-EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:35.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-32879</udiDi>
    <basicUdiDi>B-32879</basicUdiDi>
    <tradeName>D-32879</tradeName>
    <deviceName>Cancer Antigen 15-3 Quantitative Detection KIT (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Shanghai Kehua Bio-engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026756</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:26:05.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912723035</udiDi>
    <basicUdiDi>692591270025GZ</basicUdiDi>
    <tradeName>iFlash-CA 15-3</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86006-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:10.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>17350066140081</udiDi>
    <basicUdiDi>B-17350066140081</basicUdiDi>
    <tradeName>CanAg CA15-3 EIA</tradeName>
    <deviceName>CanAg CA15-3 EIA</deviceName>
    <manufacturerName>Fujirebio Diagnostics AB</manufacturerName>
    <manufacturerSrn>SE-MF-000007811</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200-10</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:14:26.531Z</lastUpdated>
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    <udiDi>14562185399438</udiDi>
    <basicUdiDi>B-14562185399438</basicUdiDi>
    <tradeName>14562185399438</tradeName>
    <deviceName>CL AIA-PACK 27.29 ADJUSTER SET</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029211</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:29.410Z</lastUpdated>
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  <row>
    <udiDi>14562185399421</udiDi>
    <basicUdiDi>B-14562185399421</basicUdiDi>
    <tradeName>14562185399421</tradeName>
    <deviceName>CL AIA-PACK 27.29 TEST CUP</deviceName>
    <manufacturerName>Tosoh Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000024143</manufacturerSrn>
    <authorisedRepresentativeName>Tosoh Europe N.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000211</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029111</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:05:27.807Z</lastUpdated>
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    <udiDi>08684595030219</udiDi>
    <basicUdiDi>B-08684595030219</basicUdiDi>
    <tradeName>RapidFor™ CA 15-3 Rapid Test Kit (FIA)</tradeName>
    <deviceName>CA 15-3 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>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VMPO84</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T03:13:08.287Z</lastUpdated>
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    <udiDi>06979355924979</udiDi>
    <basicUdiDi>B-06979355924979</basicUdiDi>
    <tradeName>06979355924979</tradeName>
    <deviceName>Cancer antigen 15-3 (CA15-3) Quantitative Test Kit(Chemiluminescent Immunoassay,CLIA)</deviceName>
    <manufacturerName>JIANGSU CONFIDENCE MEDICAL TECHNOLOGY CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000050949</manufacturerSrn>
    <authorisedRepresentativeName>JOYSUN GROUP S.L.U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000043666</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit (including calibration and control)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T23:19:24.386Z</lastUpdated>
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</eudamedExport>