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<eudamedExport entity="devices">
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    <udiDi>++B261CANE420DB</udiDi>
    <basicUdiDi>B-++B261CANE420DB</basicUdiDi>
    <tradeName>++B261CANE420DB</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-E-420</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:03.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211615</udiDi>
    <basicUdiDi>150995905DSL8700GE</basicUdiDi>
    <tradeName>Estrone RIA</tradeName>
    <deviceName>Estrone RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL8700</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:43:11.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590211547</udiDi>
    <basicUdiDi>150995905DSL5400FA</basicUdiDi>
    <tradeName>Estrone Sulfate RIA</tradeName>
    <deviceName>Estrone Sulfate RIA</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSL5400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:43:04.680Z</lastUpdated>
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  <row>
    <udiDi>D-VID5334</udiDi>
    <basicUdiDi>B-VID5334</basicUdiDi>
    <tradeName>Estrone-3-Glucuronide Test Kit (FIA)</tradeName>
    <deviceName>Estrone-3-Glucuronide Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID53-05-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:54.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325030206</udiDi>
    <basicUdiDi>B-04049325030206</basicUdiDi>
    <tradeName>Estrone ELISA</tradeName>
    <deviceName>Estrone ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DB52051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:52.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325009035</udiDi>
    <basicUdiDi>B-04049325009035</basicUdiDi>
    <tradeName>Estrone Saliva ELISA</tradeName>
    <deviceName>Estrone Saliva ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE52681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:11:08.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970522649558</udiDi>
    <basicUdiDi>B-06970522649558</basicUdiDi>
    <tradeName>Progesterone (Prog) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Progesterone (Prog) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050204</emdnCode>
    <emdnDescription>ESTRONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL1602</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:48:34.937Z</lastUpdated>
  </row>
</eudamedExport>