<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05055273220001</udiDi>
    <basicUdiDi>50552732CTXPLXU068B8</basicUdiDi>
    <tradeName>Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array</tradeName>
    <deviceName>Evidence MultiSTAT Drugs of Abuse (DOA) ToxPlex Urine Array</deviceName>
    <manufacturerName>Randox Laboratories Limited</manufacturerName>
    <manufacturerSrn>XI-MF-000028410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EV4505</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:13:54.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590030179</udiDi>
    <basicUdiDi>150995902OSR6318N3</basicUdiDi>
    <tradeName>EDDP</tradeName>
    <deviceName>EDDP</deviceName>
    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6318</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:30:20.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DIP-4-AQV</udiDi>
    <basicUdiDi>B-DIP-4-AQV</basicUdiDi>
    <tradeName>Diphenoxylate (DIP) Rapid Test Panel</tradeName>
    <deviceName>Diphenoxylate (DIP) Rapid Test Panel</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIP-4-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:26.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DIP-1-AQE</udiDi>
    <basicUdiDi>B-DIP-1-AQE</basicUdiDi>
    <tradeName>Diphenoxylate (DIP) Rapid Test Dipstick</tradeName>
    <deviceName>Diphenoxylate (DIP) Rapid Test Dipstick</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIP-1-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:25.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DIP-2-AQK</udiDi>
    <basicUdiDi>B-DIP-2-AQK</basicUdiDi>
    <tradeName>Diphenoxylate (DIP) Rapid Test Cassette</tradeName>
    <deviceName>Diphenoxylate (DIP) Rapid Test Cassette</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIP-2-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:47:35.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ARP-4-ASX</udiDi>
    <basicUdiDi>B-ARP-4-ASX</basicUdiDi>
    <tradeName>Aripiprazole (ARP) Rapid Test Panel</tradeName>
    <deviceName>Aripiprazole (ARP) Rapid Test Panel</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARP-4-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:28.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CBZ-4-AQX</udiDi>
    <basicUdiDi>B-CBZ-4-AQX</basicUdiDi>
    <tradeName>Carbamazepine (CBZ) Rapid Test Panel</tradeName>
    <deviceName>Carbamazepine (CBZ) Rapid Test Panel</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBZ-4-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:11.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CBZ-2-AQM</udiDi>
    <basicUdiDi>B-CBZ-2-AQM</basicUdiDi>
    <tradeName>Carbamazepine (CBZ) Rapid Test Cassette</tradeName>
    <deviceName>Carbamazepine (CBZ) Rapid Test Cassette</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBZ-2-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:10.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CBZ-1-AQG</udiDi>
    <basicUdiDi>B-CBZ-1-AQG</basicUdiDi>
    <tradeName>Carbamazepine (CBZ) Rapid Test Dipstick</tradeName>
    <deviceName>Carbamazepine (CBZ) Rapid Test Dipstick</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBZ-1-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:09.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ARP-2-ASM</udiDi>
    <basicUdiDi>B-ARP-2-ASM</basicUdiDi>
    <tradeName>Aripiprazole (ARP) Rapid Test Cassette</tradeName>
    <deviceName>Aripiprazole (ARP) Rapid Test Cassette</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARP-2-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:06.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ARP-1-ASG</udiDi>
    <basicUdiDi>B-ARP-1-ASG</basicUdiDi>
    <tradeName>Aripiprazole (ARP) Rapid Test Dipstick</tradeName>
    <deviceName>Aripiprazole (ARP) Rapid Test Dipstick</deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARP-1-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:06.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TLT01E194</udiDi>
    <basicUdiDi>B-L11-TLT01E194</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TLT01E1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:41.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TLT01C18W</udiDi>
    <basicUdiDi>B-L11-TLT01C18W</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TLT01C1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:39.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TLT01B18T</udiDi>
    <basicUdiDi>B-L11-TLT01B18T</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TLT01B1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:37.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TLT01A18Q</udiDi>
    <basicUdiDi>B-L11-TLT01A18Q</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tiletamine (TLTM) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TLT01A1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:30.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TIA01E1Z9</udiDi>
    <basicUdiDi>B-L11-TIA01E1Z9</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TIA01E1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:30.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TIA01C1Z3</udiDi>
    <basicUdiDi>B-L11-TIA01C1Z3</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TIA01C1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:29.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TIA01B1YY</udiDi>
    <basicUdiDi>B-L11-TIA01B1YY</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TIA01B1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:27.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-TIA01A1YV</udiDi>
    <basicUdiDi>B-L11-TIA01A1YV</basicUdiDi>
    <tradeName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Tianeptine (TIA) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-TIA01A1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:20.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-L11-PRT01E19E</udiDi>
    <basicUdiDi>B-L11-PRT01E19E</basicUdiDi>
    <tradeName>One Step Single Drug Test - Paroxetine (PRT) (Urine)</tradeName>
    <deviceName>One Step Single Drug Test - Paroxetine (PRT) (Urine)</deviceName>
    <manufacturerName>Newlink Biotech co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045176</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L11-PRT01E1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:09:20.054Z</lastUpdated>
  </row>
</eudamedExport>