<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060654860622</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-IT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:51.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860615</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-ES</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:50.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860608</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-NL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:49.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860592</udiDi>
    <basicUdiDi>506065486CYP2C19-CTRL01RT</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYP2C19-CTRL10-FR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:49.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860561</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-TR</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:47.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860554</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-PT</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:46.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860547</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-DE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:45.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860530</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-EL</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:44.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860523</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-IT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:43.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860516</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-ES</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:42.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860509</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-NL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:41.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860493</udiDi>
    <basicUdiDi>506065486ID-CYP2C19-0197</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106030101</emdnCode>
    <emdnDescription>CYP 450 - INDIVIDUAL TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-CYP2C19-10-FR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:40.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860417</udiDi>
    <basicUdiDi>506065486GS-00X2F</basicUdiDi>
    <tradeName>Genedrive® System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-002 V6.0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:39.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860332</udiDi>
    <basicUdiDi>B-05060654860332</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 Negative Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNR1-CTRL-03</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:38.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860325</udiDi>
    <basicUdiDi>B-05060654860325</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 Positive Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNR1-CTRL-02</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:37.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860226</udiDi>
    <basicUdiDi>B-05060654860226</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 Control Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RNR1-CTRL-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:36.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860011</udiDi>
    <basicUdiDi>B-05060654860011</basicUdiDi>
    <tradeName>Genedrive® MT-RNR1 ID Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ID-RNR1-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-19T21:43:34.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060654860868</udiDi>
    <basicUdiDi>506065486CK-CYP2C19-019L</basicUdiDi>
    <tradeName>Genedrive® CYP2C19 Collection Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Genedrive Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000012810</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W05019099</emdnCode>
    <emdnDescription>SAMPLES COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CK-CYP2C19-10-PL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:06:50.884Z</lastUpdated>
  </row>
</eudamedExport>