<?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-DXM-4-AVX</udiDi>
    <basicUdiDi>B-DXM-4-AVX</basicUdiDi>
    <tradeName>Dextromethorphan (DXM) Rapid Test Panel</tradeName>
    <deviceName>Dextromethorphan (DXM) 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>W0102090118</emdnCode>
    <emdnDescription>DEXTROMETHORPHAN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXM-4-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:31.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DXM-2-AVM</udiDi>
    <basicUdiDi>B-DXM-2-AVM</basicUdiDi>
    <tradeName>Dextromethorphan (DXM) Rapid Test Cassette</tradeName>
    <deviceName>Dextromethorphan (DXM) 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>W0102090118</emdnCode>
    <emdnDescription>DEXTROMETHORPHAN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXM-2-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:27.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DXM-1-AVG</udiDi>
    <basicUdiDi>B-DXM-1-AVG</basicUdiDi>
    <tradeName>Dextromethorphan (DXM) Rapid Test Dipstick</tradeName>
    <deviceName>Dextromethorphan (DXM) 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>W0102090118</emdnCode>
    <emdnDescription>DEXTROMETHORPHAN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DXM-1-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:27.166Z</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-COD-1-AN7</udiDi>
    <basicUdiDi>B-COD-1-AN7</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test Dipstick</tradeName>
    <deviceName>Codeine (COD) 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>W0102090107</emdnCode>
    <emdnDescription>CODEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COD-1-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:47:33.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COD-4-ANN</udiDi>
    <basicUdiDi>B-COD-4-ANN</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test Panel</tradeName>
    <deviceName>Codeine (COD) 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>W0102090107</emdnCode>
    <emdnDescription>CODEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COD-4-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:32.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-COD-2-ANC</udiDi>
    <basicUdiDi>B-COD-2-ANC</basicUdiDi>
    <tradeName>Codeine (COD) Rapid Test Cassette</tradeName>
    <deviceName>Codeine (COD) 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>W0102090107</emdnCode>
    <emdnDescription>CODEINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COD-2-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:41:29.039Z</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>00842768017148</udiDi>
    <basicUdiDi>0405686901047V4</basicUdiDi>
    <tradeName>Emit d.a.u. Amphetamine Class Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_KIT_Amphetamine Class Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090101</emdnCode>
    <emdnDescription>AMPHETAMINES GROUP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445253</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T20:04:15.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414601106</udiDi>
    <basicUdiDi>0405686901069VE</basicUdiDi>
    <tradeName>Emit II Plus Buprenorphine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Buprenorphine Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:49:05.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414601120</udiDi>
    <basicUdiDi>0405686901069VE</basicUdiDi>
    <tradeName>Emit II Plus Buprenorphine Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10720048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:45:13.355Z</lastUpdated>
  </row>
</eudamedExport>