<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-R16011ZW</udiDi>
    <basicUdiDi>B-R16011ZW</basicUdiDi>
    <tradeName>D-R16011ZW</tradeName>
    <deviceName>Carcinoembryonic Antigen (CEA) 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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:58.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1601427</udiDi>
    <basicUdiDi>B-R1601427</basicUdiDi>
    <tradeName>D-R1601427</tradeName>
    <deviceName>Carcinoembryonic Antigen (CEA) 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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16014</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:58.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R1601325</udiDi>
    <basicUdiDi>B-R1601325</basicUdiDi>
    <tradeName>D-R1601325</tradeName>
    <deviceName>Carcinoembryonic Antigen (CEA) 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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R16013</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:03:57.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026150846</udiDi>
    <basicUdiDi>357302BUDI000564TV</basicUdiDi>
    <tradeName>VIDAS® CEA (S)</tradeName>
    <deviceName>VIDAS® CEA (S)</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30453</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:28.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065140</udiDi>
    <basicUdiDi>357302BUDI000242T4</basicUdiDi>
    <tradeName>VIDAS® CA 15-3®</tradeName>
    <deviceName>VIDAS® CA 15-3®</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30429</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:14.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>03573026065119</udiDi>
    <basicUdiDi>357302BUDI000239TF</basicUdiDi>
    <tradeName>VIDAS® CA 125 II™</tradeName>
    <deviceName>VIDAS® CA 125 II™</deviceName>
    <manufacturerName>bioMérieux SA</manufacturerName>
    <manufacturerSrn>FR-MF-000004436</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30426</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:50:13.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414196664</udiDi>
    <basicUdiDi>0405686901799WS</basicUdiDi>
    <tradeName>ADVIA Centaur BR</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_BR</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>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10334837</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:48:51.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598048</udiDi>
    <basicUdiDi>0405686901799WS</basicUdiDi>
    <tradeName>Atellica IM BR 27.29 (BR)</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>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995477</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:46:13.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598055</udiDi>
    <basicUdiDi>0405686901799WS</basicUdiDi>
    <tradeName>Atellica IM BR 27.29 (BR)</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>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995478</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:46:13.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414196688</udiDi>
    <basicUdiDi>0405686901827W6</basicUdiDi>
    <tradeName>ADVIA Centaur BR Pretreatment Reagent</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>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10310272</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:45:14.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768013881</udiDi>
    <basicUdiDi>0405686901265VG</basicUdiDi>
    <tradeName>Dimension Free Prostate Specific Antigen Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Free Prostate Spcfc Antigen</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444888</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:21.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961118</udiDi>
    <basicUdiDi>0405686901443VG</basicUdiDi>
    <tradeName>IMMULITE 2000 CEA</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_Carcinoembryonic Antigen</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10380994</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:43.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414961088</udiDi>
    <basicUdiDi>0405686901441VC</basicUdiDi>
    <tradeName>IMMULITE 2000 BR-MA</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_C_KIT_BR-MA</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</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>10380983</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:38.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598680</udiDi>
    <basicUdiDi>0405686901806VW</basicUdiDi>
    <tradeName>Atellica IM Complexed Prostate-Specific Antigen (cPSA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_cPSA</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>W0102030115</emdnCode>
    <emdnDescription>COMPLEXED PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995544</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:09.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598079</udiDi>
    <basicUdiDi>0405686901827W6</basicUdiDi>
    <tradeName>Atellica IM BR 27.29 Pretreatment Reagent (BR PRE)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_BR Pretreatment</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>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:05.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414598505</udiDi>
    <basicUdiDi>0405686901803VQ</basicUdiDi>
    <tradeName>Atellica IM Carcinoembryonic Antigen (CEA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_CEA</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>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10995523</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:40:03.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414461304</udiDi>
    <basicUdiDi>0405686901800VJ</basicUdiDi>
    <tradeName>ADVIA Centaur CA 125II</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_CA 125II</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>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10315696</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:36.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414196657</udiDi>
    <basicUdiDi>0405686901799WS</basicUdiDi>
    <tradeName>ADVIA Centaur BR</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_KIT_BR</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>W0102030110</emdnCode>
    <emdnDescription>CANCER ANTIGEN 27.29</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10333349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:22.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GECEA-402aOGJW</udiDi>
    <basicUdiDi>B-GECEA-402aOGJW</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>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>2026-07-17T04:02:40.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A038D8</udiDi>
    <basicUdiDi>B-A038D8</basicUdiDi>
    <tradeName>INDICAID™ Bladder Cancer Marker NMP22 Test</tradeName>
    <deviceName>INDICAID™ Bladder Cancer Marker NMP22 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>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Bladder Cancer Marker NMP22 Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:54.488Z</lastUpdated>
  </row>
</eudamedExport>