<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03701516402063</udiDi>
    <basicUdiDi>37015164ETHANOLGJ</basicUdiDi>
    <tradeName>Syntri SafeguardTM  Denatured Absoltue Alcohol</tradeName>
    <deviceName>DEHYDRANT</deviceName>
    <manufacturerName>LAURYPATH</manufacturerName>
    <manufacturerSrn>FR-MF-000020948</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6215SS-LP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:42:25.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAL-114KE</udiDi>
    <basicUdiDi>B-DAL-114KE</basicUdiDi>
    <tradeName>Alcohol Rapid Test Panel</tradeName>
    <deviceName>Alcohol Rapid Test Panel</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAL-114</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:30:26.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAL-102K7</udiDi>
    <basicUdiDi>B-DAL-102K7</basicUdiDi>
    <tradeName>Alcohol Rapid Test Cassette</tradeName>
    <deviceName>Alcohol Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAL-102</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:30:24.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAL-101K5</udiDi>
    <basicUdiDi>B-DAL-101K5</basicUdiDi>
    <tradeName>Alcohol Test Dipstick</tradeName>
    <deviceName>Alcohol Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAL-101</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:30:22.548Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-DOA73M25S7Y</udiDi>
    <basicUdiDi>B-D-DOA73M25S7Y</basicUdiDi>
    <tradeName>"Etomidate (ETO) Rapid Test Midstream  -Saliva"</tradeName>
    <deviceName>Etomidate (ETO) Rapid Test Midstream  -Saliva</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-DOA73M25S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:30:21.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-D-DOA73D20S5J</udiDi>
    <basicUdiDi>B-D-DOA73D20S5J</basicUdiDi>
    <tradeName>Etomidate (ETO) Rapid Test Device-Saliva</tradeName>
    <deviceName>Etomidate (ETO) Rapid Test Device-Saliva</deviceName>
    <manufacturerName>Rapid Labs Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026335</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-DOA73D20S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:30:20.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768001550</udiDi>
    <basicUdiDi>0405686901227V8</basicUdiDi>
    <tradeName>Emit tox Acetaminophen Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445385</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:53.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768022050</udiDi>
    <basicUdiDi>0405686901106UT</basicUdiDi>
    <tradeName>Dimension Ethyl alcohol Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Ethyl alcohol</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>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10459408</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:19:53.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768005787</udiDi>
    <basicUdiDi>0405686900208UV</basicUdiDi>
    <tradeName>Dimension Acetaminophen Flex reagent cartridge</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_ACTM</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10444916</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-21T19:49:31.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768002021</udiDi>
    <basicUdiDi>0405686901107UV</basicUdiDi>
    <tradeName>Emit II Plus Ethyl Alcohol Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol 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>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445452</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:42:14.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414595894</udiDi>
    <basicUdiDi>0405686900811VG</basicUdiDi>
    <tradeName>Atellica CH Acetaminophen (Acet)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_C_REAG_ACET</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097522</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:43.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768014413</udiDi>
    <basicUdiDi>0405686901107UV</basicUdiDi>
    <tradeName>Emit II Plus Ethyl Alcohol 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>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445446</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:35:47.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768002038</udiDi>
    <basicUdiDi>0405686901107UV</basicUdiDi>
    <tradeName>Emit II Plus Ethyl Alcohol 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>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445453</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:35:42.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBALC-101aOGJY</udiDi>
    <basicUdiDi>B-GBALC-101aOGJY</basicUdiDi>
    <tradeName>Urine Alcohol Test Strip</tradeName>
    <deviceName>Urine Alcohol Test Strip</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBALC-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:03:39.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>50604284400430</udiDi>
    <basicUdiDi>B-50604284400430</basicUdiDi>
    <tradeName>50604284400430</tradeName>
    <deviceName>Salicylate Enzyme Assay Kit</deviceName>
    <manufacturerName>Cambridge Life Sciences Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000026451</manufacturerSrn>
    <authorisedRepresentativeName>Glenbio Ireland Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000024936</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090213</emdnCode>
    <emdnDescription>SALICYLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K9001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:12:55.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003469</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Assay</tradeName>
    <deviceName>ARK Ethyl Glucuronide Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:01.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850624008568</udiDi>
    <basicUdiDi>0850624008EIAEtG30225</basicUdiDi>
    <tradeName>Ethyl Glucuronide III Enzyme Immunoassay</tradeName>
    <deviceName>Ethyl Glucuronide III Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09976523190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:30.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596112</udiDi>
    <basicUdiDi>0405686901708VV</basicUdiDi>
    <tradeName>Atellica CH Ethyl Alcohol (ETOH)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ETOH</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:08.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023439</udiDi>
    <basicUdiDi>0405686901107UV</basicUdiDi>
    <tradeName>Emit® II Plus Ethyl Alcohol Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Ethyl Alcohol 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>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445451</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:36.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768023330</udiDi>
    <basicUdiDi>0405686901227V8</basicUdiDi>
    <tradeName>Emit® tox™ Acetaminophen Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_C_REAG_Acetaminophen 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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445384</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:30:13.674Z</lastUpdated>
  </row>
</eudamedExport>