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<eudamedExport entity="devices">
  <row>
    <udiDi>++B261CANTE300K5</udiDi>
    <basicUdiDi>B-++B261CANTE300K5</basicUdiDi>
    <tradeName>++B261CANTE300K5</tradeName>
    <deviceName>Testosterone Saliva ELISA</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>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-TE-300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:58.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANTE250KF</udiDi>
    <basicUdiDi>B-++B261CANTE250KF</basicUdiDi>
    <tradeName>++B261CANTE250KF</tradeName>
    <deviceName>Testosterone ELISA</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>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-TE-250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:55.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANSHBG4010D9</udiDi>
    <basicUdiDi>B-++B261CANSHBG4010D9</basicUdiDi>
    <tradeName>++B261CANSHBG4010D9</tradeName>
    <deviceName>Sex Hormone Binding Globulin (SHBG) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-SHBG-4010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:51.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANPRL41004G</udiDi>
    <basicUdiDi>B-++B261CANPRL41004G</basicUdiDi>
    <tradeName>++B261CANPRL41004G</tradeName>
    <deviceName>Prolactin (PRL) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-PRL-4100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:45.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANP320FK</udiDi>
    <basicUdiDi>B-++B261CANP320FK</basicUdiDi>
    <tradeName>++B261CANP320FK</tradeName>
    <deviceName>17α-hydroxyprogesterone (17α-OHP) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-P-320</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:43.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANPRE45002P</udiDi>
    <basicUdiDi>B-++B261CANPRE45002P</basicUdiDi>
    <tradeName>++B261CANPRE45002P</tradeName>
    <deviceName>Pregnenolone ELISA</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>IVDD</legislation>
    <emdnCode>W0102050199</emdnCode>
    <emdnDescription>FERTILITY FUNCTION HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-PRE-4500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:41.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANP400FJ</udiDi>
    <basicUdiDi>B-++B261CANP400FJ</basicUdiDi>
    <tradeName>++B261CANP400FJ</tradeName>
    <deviceName>17α-hydroxyprogesterone (17α-OHP) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-P-400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:40.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANP310FG</udiDi>
    <basicUdiDi>B-++B261CANP310FG</basicUdiDi>
    <tradeName>++B261CANP310FG</tradeName>
    <deviceName>Progesterone Saliva ELISA</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>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-P-310</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:24.189Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANP305FP</udiDi>
    <basicUdiDi>B-++B261CANP305FP</basicUdiDi>
    <tradeName>++B261CANP305FP</tradeName>
    <deviceName>Progesterone ELISA</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>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-P-305</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:24.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANLH4040JK</udiDi>
    <basicUdiDi>B-++B261CANLH4040JK</basicUdiDi>
    <tradeName>++B261CANLH4040JK</tradeName>
    <deviceName>Luteinizing Hormone (hLH) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-LH-4040</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:22.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANFTE260Q9</udiDi>
    <basicUdiDi>B-++B261CANFTE260Q9</basicUdiDi>
    <tradeName>++B261CANFTE260Q9</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>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-FTE-260</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:15.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANFSH4060WH</udiDi>
    <basicUdiDi>B-++B261CANFSH4060WH</basicUdiDi>
    <tradeName>++B261CANFSH4060WH</tradeName>
    <deviceName>Follicle Stimulating Hormone (FSH) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-FSH-4060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:09.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANE430DE</udiDi>
    <basicUdiDi>B-++B261CANE430DE</basicUdiDi>
    <tradeName>++B261CANE430DE</tradeName>
    <deviceName>Estradiol ELISA</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>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-E-430</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:03.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANDHT280NS</udiDi>
    <basicUdiDi>B-++B261CANDHT280NS</basicUdiDi>
    <tradeName>++B261CANDHT280NS</tradeName>
    <deviceName>Dihydrotestosterone (DHT) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-DHT-280</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:58.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANDHS480NV</udiDi>
    <basicUdiDi>B-++B261CANDHS480NV</basicUdiDi>
    <tradeName>++B261CANDHS480NV</tradeName>
    <deviceName>Dehydroepiandrosterone Sulphate (DHEAS) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-DHS-480</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:58.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANDH490FA</udiDi>
    <basicUdiDi>B-++B261CANDH490FA</basicUdiDi>
    <tradeName>++B261CANDH490FA</tradeName>
    <deviceName>Dehydroepiandrosterone (DHEA) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-DH-490</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:56.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANDG460ES</udiDi>
    <basicUdiDi>B-++B261CANDG460ES</basicUdiDi>
    <tradeName>++B261CANDG460ES</tradeName>
    <deviceName>5α-Androstane-3α, 17ß-diol Glucuronide (3α Diol G) ELISA</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>IVDD</legislation>
    <emdnCode>W0102050112</emdnCode>
    <emdnDescription>ANDROSTANEDIOL-GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-DG-460</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:56.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B261CANAD208CQ</udiDi>
    <basicUdiDi>B-++B261CANAD208CQ</basicUdiDi>
    <tradeName>++B261CANAD208CQ</tradeName>
    <deviceName>Androstenedione ELISA</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>IVDD</legislation>
    <emdnCode>W0102050101</emdnCode>
    <emdnDescription>ANDROSTENEDIONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-AD-208</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:39:24.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806133040997</udiDi>
    <basicUdiDi>880613300519CH</basicUdiDi>
    <tradeName>AFIAS Testosterone</tradeName>
    <deviceName>AFIAS Testosterone</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-29</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:00:34.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075098</udiDi>
    <basicUdiDi>69703416803205076JU</basicUdiDi>
    <tradeName>free TESTO (eCLIA)</tradeName>
    <deviceName>free TESTO (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 B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:14:22.928Z</lastUpdated>
  </row>
</eudamedExport>