<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-475009QD</udiDi>
    <basicUdiDi>B-475009QD</basicUdiDi>
    <tradeName>Phencyclidine Reagent (PCP 1 x 250)</tradeName>
    <deviceName>Phencyclidine Reagent (PCP 1 x 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475009</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:05:25.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475006Q7</udiDi>
    <basicUdiDi>B-475006Q7</basicUdiDi>
    <tradeName>Opiate 2000 ng Reagent (OP2 1 x 250)</tradeName>
    <deviceName>Opiate 2000 ng Reagent (OP2 1 x 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:05:25.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475003PZ</udiDi>
    <basicUdiDi>B-475003PZ</basicUdiDi>
    <tradeName>Cocaine Metabolite Reagent (COCM 1 x 250)</tradeName>
    <deviceName>Cocaine Metabolite Reagent (COCM 1 x 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:05:13.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475000PT</udiDi>
    <basicUdiDi>B-475000PT</basicUdiDi>
    <tradeName>Amphetamines Reagent (AMPH 1 x 250)</tradeName>
    <deviceName>Amphetamines Reagent (AMPH 1 x 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090102</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:05:04.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-474947RT</udiDi>
    <basicUdiDi>B-474947RT</basicUdiDi>
    <tradeName>Alcohol Reagent (ETOH 2 x 150)</tradeName>
    <deviceName>Alcohol Reagent (ETOH 2 x 150)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>474947</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:31.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-472169QF</udiDi>
    <basicUdiDi>B-472169QF</basicUdiDi>
    <tradeName>Acetaminophen Reagent (ACTM 100)</tradeName>
    <deviceName>Acetaminophen Reagent (ACTM 100)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>472169</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:50.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445990R2</udiDi>
    <basicUdiDi>B-445990R2</basicUdiDi>
    <tradeName>Cannabinoid 100 ng Reagent (THC 1 x 150)</tradeName>
    <deviceName>Cannabinoid 100 ng Reagent (THC 1 x 150)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445990</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:54.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-445824QG</udiDi>
    <basicUdiDi>B-445824QG</basicUdiDi>
    <tradeName>Cannabinoid 20 ng Reagent (THC2 1 x 150)</tradeName>
    <deviceName>Cannabinoid 20 ng Reagent (THC2 1 x 150)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>445824</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:33.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-378194RB</udiDi>
    <basicUdiDi>B-378194RB</basicUdiDi>
    <tradeName>Salicylate Reagent (SALY 2 x 45)</tradeName>
    <deviceName>Salicylate Reagent (SALY 2 x 45)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090213</emdnCode>
    <emdnDescription>SALICYLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>378194</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:57:40.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30523-FRAQ5</udiDi>
    <basicUdiDi>B-30523-FRAQ5</basicUdiDi>
    <tradeName>TheraCHECK Dip Drug Test</tradeName>
    <deviceName>TheraCHECK DIP DRUG TEST - AMP BZO COC OPI300 THC</deviceName>
    <manufacturerName>CareHealth America Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025798</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30523-FRA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:08:16.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-30170C-FRAAK</udiDi>
    <basicUdiDi>B-30170C-FRAAK</basicUdiDi>
    <tradeName>TheraCHECK Dip Drug Test</tradeName>
    <deviceName>TheraCHECK Single Dip Cassette Drug Test - BZO</deviceName>
    <manufacturerName>CareHealth America Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000025798</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30170C-FRA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:07:22.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817373</udiDi>
    <basicUdiDi>B-16438153817373</basicUdiDi>
    <tradeName>16438153817373</tradeName>
    <deviceName>DoA Control set E</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981737</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:46:03.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817335</udiDi>
    <basicUdiDi>B-16438153817335</basicUdiDi>
    <tradeName>16438153817335</tradeName>
    <deviceName>DoA Control set C</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981733</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:46:01.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817281</udiDi>
    <basicUdiDi>B-16438153817281</basicUdiDi>
    <tradeName>16438153817281</tradeName>
    <deviceName>DoA Control set B</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981728</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:54.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153817236</udiDi>
    <basicUdiDi>B-16438153817236</basicUdiDi>
    <tradeName>16438153817236</tradeName>
    <deviceName>DoA Control set A</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981723</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:49.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153816833</udiDi>
    <basicUdiDi>B-16438153816833</basicUdiDi>
    <tradeName>METHADONE</tradeName>
    <deviceName>Methadone</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981683</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:27.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153816802</udiDi>
    <basicUdiDi>B-16438153816802</basicUdiDi>
    <tradeName>W0102090207</tradeName>
    <deviceName>Ethyl Alcohol</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981680</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:22.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153816253</udiDi>
    <basicUdiDi>B-16438153816253</basicUdiDi>
    <tradeName>OPIATES</tradeName>
    <deviceName>Opiates</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981625</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:21.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153816246</udiDi>
    <basicUdiDi>B-16438153816246</basicUdiDi>
    <tradeName>COCAINE METABOLITE</tradeName>
    <deviceName>COCAINE METABOLITE</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981624</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:20.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>16438153816239</udiDi>
    <basicUdiDi>B-16438153816239</basicUdiDi>
    <tradeName>CANNABINOIDS</tradeName>
    <deviceName>Cannabinoids</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>981623</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:45:20.085Z</lastUpdated>
  </row>
</eudamedExport>