<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-MDMA-05-25tHH</udiDi>
    <basicUdiDi>B-MDMA-05-25tHH</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:32.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDMA-02-25tGG</udiDi>
    <basicUdiDi>B-MDMA-02-25tGG</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:32.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDMA-01-100tBV</udiDi>
    <basicUdiDi>B-MDMA-01-100tBV</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methylenedioxymethamphetamine (MDMA) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDMA-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:29.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566303469</udiDi>
    <basicUdiDi>B-06974566303469</basicUdiDi>
    <tradeName>Ecstasy(MDMA)  Rapid Test</tradeName>
    <deviceName>Ecstasy(MDMA)  Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMD-105</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:00.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974566303452</udiDi>
    <basicUdiDi>B-06974566303452</basicUdiDi>
    <tradeName>EDDP Rapid Test</tradeName>
    <deviceName>EDDP Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DED-105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:56:59.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883011342</udiDi>
    <basicUdiDi>B-00884883011342</basicUdiDi>
    <tradeName>00884883011342</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>10014681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:20.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008083</udiDi>
    <basicUdiDi>B-00884883008083</basicUdiDi>
    <tradeName>00884883008083</tradeName>
    <deviceName>ARCHITECT Ecstasy 500 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>3L42-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:46.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008090</udiDi>
    <basicUdiDi>B-00884883008090</basicUdiDi>
    <tradeName>00884883008090</tradeName>
    <deviceName>ARCHITECT Ecstasy 750 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>3L42-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:44.480Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008076</udiDi>
    <basicUdiDi>B-00884883008076</basicUdiDi>
    <tradeName>00884883008076</tradeName>
    <deviceName>ARCHITECT Ecstasy 250 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>3L42-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:28.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008069</udiDi>
    <basicUdiDi>B-00884883008069</basicUdiDi>
    <tradeName>00884883008069</tradeName>
    <deviceName>ARCHITECT Ecstasy 1000 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>3L42-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:27.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008052</udiDi>
    <basicUdiDi>B-00884883008052</basicUdiDi>
    <tradeName>00884883008052</tradeName>
    <deviceName>ARCHITECT Ecstasy Reagent</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>3L42-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:26.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008045</udiDi>
    <basicUdiDi>B-00884883008045</basicUdiDi>
    <tradeName>00884883008045</tradeName>
    <deviceName>Alinity c Ecstasy Semiquant 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>09P5802</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:25.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883008021</udiDi>
    <basicUdiDi>B-00884883008021</basicUdiDi>
    <tradeName>00884883008021</tradeName>
    <deviceName>Alinity c Ecstasy Qual 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>W0102090119</emdnCode>
    <emdnDescription>MDMA (ECSTASY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P5801</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:25:21.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002883</udiDi>
    <basicUdiDi>B-00884883002883</basicUdiDi>
    <tradeName>00884883002883</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>100076</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:46.056Z</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>
</eudamedExport>