<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GBEDD-102aNM</udiDi>
    <basicUdiDi>B-GBEDD-102aNM</basicUdiDi>
    <tradeName>One Step EDDP Test Cassette (Urine)</tradeName>
    <deviceName>One Step EDDP Test Cassette (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBEDD-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:21.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBEDD-101aNJ</udiDi>
    <basicUdiDi>B-GBEDD-101aNJ</basicUdiDi>
    <tradeName>One Step EDDP Test Strip (Urine)</tradeName>
    <deviceName>One Step EDDP Test Strip (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBEDD-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:17:14.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EDDP-05-25tC7</udiDi>
    <basicUdiDi>B-EDDP-05-25tC7</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone Metabolite (EDDP) 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-05-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:49.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EDDP-02-25tB6</udiDi>
    <basicUdiDi>B-EDDP-02-25tB6</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone Metabolite (EDDP) 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-02-25t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:45.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EDDP-01-100t59</udiDi>
    <basicUdiDi>B-EDDP-01-100t59</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Methadone Metabolite (EDDP) 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDDP-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:46:45.010Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883012912</udiDi>
    <basicUdiDi>B-00884883012912</basicUdiDi>
    <tradeName>00884883012912</tradeName>
    <deviceName>DRI Methadone Metabolite 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018522</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:22.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005105</udiDi>
    <basicUdiDi>B-00884883005105</basicUdiDi>
    <tradeName>00884883005105</tradeName>
    <deviceName>DRI Methadone Metabolite 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:21:43.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005112</udiDi>
    <basicUdiDi>B-00884883005112</basicUdiDi>
    <tradeName>00884883005112</tradeName>
    <deviceName>DRI Methadone Metabolite 2000 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:21:40.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005099</udiDi>
    <basicUdiDi>B-00884883005099</basicUdiDi>
    <tradeName>00884883005099</tradeName>
    <deviceName>DRI Methadone Metabolite 300 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100118</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:21:24.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883005082</udiDi>
    <basicUdiDi>B-00884883005082</basicUdiDi>
    <tradeName>00884883005082</tradeName>
    <deviceName>DRI Methadone Metabolite 150 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100117</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:21:23.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883003408</udiDi>
    <basicUdiDi>B-00884883003408</basicUdiDi>
    <tradeName>00884883003408</tradeName>
    <deviceName>DRI Methadone Metabolite 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100115</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:16:06.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002920</udiDi>
    <basicUdiDi>B-00884883002920</basicUdiDi>
    <tradeName>00884883002920</tradeName>
    <deviceName>DRI Methadone Metabolite 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>W0102090120</emdnCode>
    <emdnDescription>EDDP SPECIFIC (METHADONE METABOLITES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:47.658Z</lastUpdated>
  </row>
</eudamedExport>