<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00884883001428</udiDi>
    <basicUdiDi>B-00884883001428</basicUdiDi>
    <tradeName>00884883001428</tradeName>
    <deviceName>CEDIA Benzodiazepine 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>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:45.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001398</udiDi>
    <basicUdiDi>B-00884883001398</basicUdiDi>
    <tradeName>00884883001398</tradeName>
    <deviceName>DRI Ecstasy 500 ng/mL 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100081</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:43.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001404</udiDi>
    <basicUdiDi>B-00884883001404</basicUdiDi>
    <tradeName>00884883001404</tradeName>
    <deviceName>DRI Ecstasy 250 ng/mL 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100082</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:42.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001381</udiDi>
    <basicUdiDi>B-00884883001381</basicUdiDi>
    <tradeName>00884883001381</tradeName>
    <deviceName>DRI Ecstasy 750 ng/mL 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:27.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001374</udiDi>
    <basicUdiDi>B-00884883001374</basicUdiDi>
    <tradeName>00884883001374</tradeName>
    <deviceName>DRI Ecstasy 1000 ng/mL 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100079</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:26.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001350</udiDi>
    <basicUdiDi>B-00884883001350</basicUdiDi>
    <tradeName>00884883001350</tradeName>
    <deviceName>DRI Ecstasy 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100075</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:24.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001343</udiDi>
    <basicUdiDi>B-00884883001343</basicUdiDi>
    <tradeName>00884883001343</tradeName>
    <deviceName>CEDIA Heroin Metabolite (6-AM) High 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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100034</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:22.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001336</udiDi>
    <basicUdiDi>B-00884883001336</basicUdiDi>
    <tradeName>00884883001336</tradeName>
    <deviceName>CEDIA Heroin Metabolite (6-AM) Cutoff-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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:20.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001329</udiDi>
    <basicUdiDi>B-00884883001329</basicUdiDi>
    <tradeName>00884883001329</tradeName>
    <deviceName>CEDIA AntibioticTDM Multi-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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100017</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:20.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001312</udiDi>
    <basicUdiDi>B-00884883001312</basicUdiDi>
    <tradeName>00884883001312</tradeName>
    <deviceName>CEDIA Gentamicin II 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>W0102080307</emdnCode>
    <emdnDescription>GENTAMICIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:18.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001305</udiDi>
    <basicUdiDi>B-00884883001305</basicUdiDi>
    <tradeName>00884883001305</tradeName>
    <deviceName>Valproic Acid II</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>W0102080210</emdnCode>
    <emdnDescription>VALPROIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:16.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001299</udiDi>
    <basicUdiDi>B-00884883001299</basicUdiDi>
    <tradeName>00884883001299</tradeName>
    <deviceName>CEDIA Cyclosporine PLUS High Range Calibrators (450/2000)</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>W0102080601</emdnCode>
    <emdnDescription>CYCLOSPORINE TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:14.544Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001275</udiDi>
    <basicUdiDi>B-00884883001275</basicUdiDi>
    <tradeName>00884883001275</tradeName>
    <deviceName>CEDIA Theophylline II 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>W0102080402</emdnCode>
    <emdnDescription>THEOPHYLLINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:13.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001268</udiDi>
    <basicUdiDi>B-00884883001268</basicUdiDi>
    <tradeName>00884883001268</tradeName>
    <deviceName>CEDIA Core TDM Multi-Calibrators</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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100007</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:12.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001251</udiDi>
    <basicUdiDi>B-00884883001251</basicUdiDi>
    <tradeName>00884883001251</tradeName>
    <deviceName>CEDIA Carbamazepine II</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>W0102080201</emdnCode>
    <emdnDescription>CARBAMAZEPINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:09.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001237</udiDi>
    <basicUdiDi>B-00884883001237</basicUdiDi>
    <tradeName>00884883001237</tradeName>
    <deviceName>CEDIA Phenobarbital II 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>W0102080207</emdnCode>
    <emdnDescription>PHENOBARBITAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:08.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001220</udiDi>
    <basicUdiDi>B-00884883001220</basicUdiDi>
    <tradeName>00884883001220</tradeName>
    <deviceName>CEDIA Phenytoin II 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>W0102080208</emdnCode>
    <emdnDescription>PHENYTOIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:07.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001213</udiDi>
    <basicUdiDi>B-00884883001213</basicUdiDi>
    <tradeName>00884883001213</tradeName>
    <deviceName>CEDIA Cardiac TDM Multi-Calibrators</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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:05.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001206</udiDi>
    <basicUdiDi>B-00884883001206</basicUdiDi>
    <tradeName>00884883001206</tradeName>
    <deviceName>DRI Digoxin 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>W0102080101</emdnCode>
    <emdnDescription>DIGOXIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1669</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:03.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001190</udiDi>
    <basicUdiDi>B-00884883001190</basicUdiDi>
    <tradeName>00884883001190</tradeName>
    <deviceName>DRI Negative Urine 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>W01021521</emdnCode>
    <emdnDescription>MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1664</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:12:01.738Z</lastUpdated>
  </row>
</eudamedExport>