<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936983126205</udiDi>
    <basicUdiDi>B-06936983126205</basicUdiDi>
    <tradeName>Test Rápido de Alcohol En Tira (Saliva)</tradeName>
    <deviceName>Test Rápido de Alcohol En Tira (Saliva)</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-801</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:19:59.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049325006447</udiDi>
    <basicUdiDi>B-04049325006447</basicUdiDi>
    <tradeName>MetCombi Plasma ELISA</tradeName>
    <deviceName>MetCombi Plasma ELISA</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090204</emdnCode>
    <emdnDescription>CATECHOLAMINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RE59202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:10:24.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012486</udiDi>
    <basicUdiDi>B-00884883012486</basicUdiDi>
    <tradeName>00884883012486</tradeName>
    <deviceName>DRI Ethyl Alcohol Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10016397</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:31:48.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008984</udiDi>
    <basicUdiDi>B-00884883008984</basicUdiDi>
    <tradeName>00884883008984</tradeName>
    <deviceName>Alinity c Tricyclic Antidepressants</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090215</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P9120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:25.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008526</udiDi>
    <basicUdiDi>B-00884883008526</basicUdiDi>
    <tradeName>00884883008526</tradeName>
    <deviceName>ARCHITECT Tricyclic Antidepressants</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090215</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6L28-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:34.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008328</udiDi>
    <basicUdiDi>B-00884883008328</basicUdiDi>
    <tradeName>00884883008328</tradeName>
    <deviceName>ARCHITECT Ethanol Negative Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L36-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:28:04.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008311</udiDi>
    <basicUdiDi>B-00884883008311</basicUdiDi>
    <tradeName>00884883008311</tradeName>
    <deviceName>ARCHITECT Ethanol 50 Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L36-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:26:16.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008304</udiDi>
    <basicUdiDi>B-00884883008304</basicUdiDi>
    <tradeName>00884883008304</tradeName>
    <deviceName>ARCHITECT Ethanol 300 Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L36-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:26:15.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008298</udiDi>
    <basicUdiDi>B-00884883008298</basicUdiDi>
    <tradeName>00884883008298</tradeName>
    <deviceName>ARCHITECT Ethanol 100 Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L36-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:26:14.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008281</udiDi>
    <basicUdiDi>B-00884883008281</basicUdiDi>
    <tradeName>00884883008281</tradeName>
    <deviceName>ARCHITECT Ethanol Reagent Kit</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3L36-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:26:12.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005556</udiDi>
    <basicUdiDi>B-00884883005556</basicUdiDi>
    <tradeName>00884883005556</tradeName>
    <deviceName>DRI T-Uptake Calibrator Kit</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0738</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:22:41.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883003453</udiDi>
    <basicUdiDi>B-00884883003453</basicUdiDi>
    <tradeName>00884883003453</tradeName>
    <deviceName>DRI T-Uptake (EIA Assay)</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0723</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:16:14.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002890</udiDi>
    <basicUdiDi>B-00884883002890</basicUdiDi>
    <tradeName>00884883002890</tradeName>
    <deviceName>DRI Ethyl Alcohol Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:45.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002784</udiDi>
    <basicUdiDi>B-00884883002784</basicUdiDi>
    <tradeName>00884883002784</tradeName>
    <deviceName>DRI Ethyl Glucuronide 625 ng/mL Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10012136</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:21.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002777</udiDi>
    <basicUdiDi>B-00884883002777</basicUdiDi>
    <tradeName>00884883002777</tradeName>
    <deviceName>DRI Ethyl Glucuronide 375 ng/mL Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10012135</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:18.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002180</udiDi>
    <basicUdiDi>B-00884883002180</basicUdiDi>
    <tradeName>00884883002180</tradeName>
    <deviceName>DRI ETG ASSAY, 68ML</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10011297</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:14:24.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001183</udiDi>
    <basicUdiDi>B-00884883001183</basicUdiDi>
    <tradeName>00884883001183</tradeName>
    <deviceName>DRI Tricyclics Serum Tox Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090299</emdnCode>
    <emdnDescription>TOXICOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:00.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001176</udiDi>
    <basicUdiDi>B-00884883001176</basicUdiDi>
    <tradeName>00884883001176</tradeName>
    <deviceName>DRI Acetaminophen Serum Tox Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:59.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001169</udiDi>
    <basicUdiDi>B-00884883001169</basicUdiDi>
    <tradeName>00884883001169</tradeName>
    <deviceName>DRI Acetaminophen Serum Tox Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1086</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:56.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001008</udiDi>
    <basicUdiDi>B-00884883001008</basicUdiDi>
    <tradeName>00884883001008</tradeName>
    <deviceName>DRI Ethyl Alcohol Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:25.660Z</lastUpdated>
  </row>
</eudamedExport>