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<eudamedExport entity="devices">
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    <udiDi>00816870020471</udiDi>
    <basicUdiDi>081687002CA1253025PQ</basicUdiDi>
    <tradeName>CA-125 AccuBind ELISA Kit - 96 wells</tradeName>
    <deviceName>Cancer Antigen 125 (CA 125) AccuBind® ELISA Test System</deviceName>
    <manufacturerName>Monobind Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021611</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3025-300A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:56:08.367Z</lastUpdated>
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  <row>
    <udiDi>D-FI-CEA-402GH</udiDi>
    <basicUdiDi>B-FI-CEA-402GH</basicUdiDi>
    <tradeName>D-FI-CEA-402GH</tradeName>
    <deviceName>CEA Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-CEA-402</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T00:39:50.882Z</lastUpdated>
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  <row>
    <udiDi>10888385000023</udiDi>
    <basicUdiDi>B-10888385000023</basicUdiDi>
    <tradeName>CellSearch Circulating Tumor Cell (CTC) Control Kit</tradeName>
    <deviceName>CellSearch Circulating Tumor Cell (CTC) Control Kit</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:26:33.902Z</lastUpdated>
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    <udiDi>00630414291345</udiDi>
    <basicUdiDi>0405686902359VZ</basicUdiDi>
    <tradeName>Atellica IM Cytokeratin Fragment 21-1 (CYFRA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CYFRA</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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11354591</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:45.670Z</lastUpdated>
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    <udiDi>08056771200462</udiDi>
    <basicUdiDi>805677131439156</basicUdiDi>
    <tradeName>LIAISON® fPSA</tradeName>
    <deviceName>LIAISON® fPSA</deviceName>
    <manufacturerName>DiaSorin Italia S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029422</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102030114</emdnCode>
    <emdnDescription>FREE PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>314391</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-28T00:40:34.716Z</lastUpdated>
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  <row>
    <udiDi>10888385000016</udiDi>
    <basicUdiDi>B-10888385000016</basicUdiDi>
    <tradeName>CellSearch Circulating Tumor Cell (CTC) Kit</tradeName>
    <deviceName>CellSearch Circulating Tumor Cell (CTC) Kit</deviceName>
    <manufacturerName>Menarini Silicon Biosystems, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000042008</manufacturerSrn>
    <authorisedRepresentativeName>Menarini Silicon Biosystems S.p.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000034891</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030199</emdnCode>
    <emdnDescription>CANCER ANTIGENS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7900001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:41:20.695Z</lastUpdated>
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  <row>
    <udiDi>D-Z003384P</udiDi>
    <basicUdiDi>B-Z003384P</basicUdiDi>
    <tradeName>D-Z003384P</tradeName>
    <deviceName>PSA</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030113</emdnCode>
    <emdnDescription>TOTAL PROSTATIC SPECIFIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z00338</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:51.208Z</lastUpdated>
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  <row>
    <udiDi>06971348765521</udiDi>
    <basicUdiDi>B-06971348765521</basicUdiDi>
    <tradeName>Human Epididymis Protein 4 (HE 4) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Human Epididymis Protein 4 (HE 4) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-09-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:50.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348765507</udiDi>
    <basicUdiDi>B-06971348765507</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragment (Cyfra21-1) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Cytokeratin 19 Fragment (Cyfra21-1) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-07-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:48.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348762315</udiDi>
    <basicUdiDi>B-06971348762315</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-06-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:38.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348762292</udiDi>
    <basicUdiDi>B-06971348762292</basicUdiDi>
    <tradeName>Carbohydrate Antigen 125 (CA125) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 125 (CA125) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-05-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:37.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348762261</udiDi>
    <basicUdiDi>B-06971348762261</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-04-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:17.258Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348762247</udiDi>
    <basicUdiDi>B-06971348762247</basicUdiDi>
    <tradeName>α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030118</emdnCode>
    <emdnDescription>CANCER ASSOCIATED SERUM ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-03-25</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:53:16.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760229</udiDi>
    <basicUdiDi>B-06971348760229</basicUdiDi>
    <tradeName>Human Epididymis Protein 4 (HE 4) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Human Epididymis Protein 4 (HE 4) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030119</emdnCode>
    <emdnDescription>HUMAN EPIDIDYMIS PROTEIN 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-09-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:34.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760120</udiDi>
    <basicUdiDi>B-06971348760120</basicUdiDi>
    <tradeName>Cytokeratin 19 Fragment (Cyfra21-1) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Cytokeratin 19 Fragment (Cyfra21-1) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-07-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:07.544Z</lastUpdated>
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    <udiDi>06971348760090</udiDi>
    <basicUdiDi>B-06971348760090</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-04-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:06.759Z</lastUpdated>
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  <row>
    <udiDi>06971348760083</udiDi>
    <basicUdiDi>B-06971348760083</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 (CA15-3) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-06-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:05.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760076</udiDi>
    <basicUdiDi>B-06971348760076</basicUdiDi>
    <tradeName>Carbohydrate Antigen 125 (CA125) Diagnostic Kit(Immunochromatographic Assay)</tradeName>
    <deviceName>Carbohydrate Antigen 125 (CA125) Diagnostic Kit(Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-05-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:01.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971348760069</udiDi>
    <basicUdiDi>B-06971348760069</basicUdiDi>
    <tradeName>α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>α-fetoprotein (AFP) Diagnostic Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Shenzhen Microprofit Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000019518</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030118</emdnCode>
    <emdnDescription>CANCER ASSOCIATED SERUM ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MF-03-20</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:52:01.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414291338</udiDi>
    <basicUdiDi>0405686902359VZ</basicUdiDi>
    <tradeName>ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_CYFRA</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>W0102030111</emdnCode>
    <emdnDescription>CYFRA 21-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11354590</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:47.324Z</lastUpdated>
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</eudamedExport>