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<eudamedExport entity="devices">
  <row>
    <udiDi>D-697994388Ir0643NEB</udiDi>
    <basicUdiDi>B-697994388Ir0643NEB</basicUdiDi>
    <tradeName>D-697994388Ir0643NEB</tradeName>
    <deviceName>MAMP Methamphetamine Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir064</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:08.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir0633LE2</udiDi>
    <basicUdiDi>B-697994388Ir0633LE2</basicUdiDi>
    <tradeName>D-697994388Ir0633LE2</tradeName>
    <deviceName>MOR Morphine Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:25:05.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840308372</udiDi>
    <basicUdiDi>B-69743840308372</basicUdiDi>
    <tradeName>One Step Multi-Drug Test Dip Card</tradeName>
    <deviceName>One Step Multi-Drug Test Dip Card</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3034401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:27.716Z</lastUpdated>
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  <row>
    <udiDi>00858724003841</udiDi>
    <basicUdiDi>0858724003EDDP0515Z</basicUdiDi>
    <tradeName>ARK EDDP Assay</tradeName>
    <deviceName>ARK EDDP 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5051-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:05.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003773</udiDi>
    <basicUdiDi>0858724003TRA0406V</basicUdiDi>
    <tradeName>ARK Tramadol Assay</tradeName>
    <deviceName>ARK Tramadol 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5040-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:04.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858724003544</udiDi>
    <basicUdiDi>0858724003MHP0423Z</basicUdiDi>
    <tradeName>ARK Methylphenidate Metabolite Assay</tradeName>
    <deviceName>ARK Methylphenidate Metabolite 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5042-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:03.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101032084</udiDi>
    <basicUdiDi>0858724003ETG0773H</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide II Assay</tradeName>
    <deviceName>ARK Ethyl Glucuronide II 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5077-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:38.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101031599</udiDi>
    <basicUdiDi>0858724003KET0833G</basicUdiDi>
    <tradeName>ARK Ketamine II Assay</tradeName>
    <deviceName>ARK Ketamine II 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5083-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:38.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101031308</udiDi>
    <basicUdiDi>0858724003ZPC04399</basicUdiDi>
    <tradeName>ARK Zopiclone Assay</tradeName>
    <deviceName>ARK Zopiclone 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5043-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:37.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030561</udiDi>
    <basicUdiDi>0858724003FEN069Y8</basicUdiDi>
    <tradeName>ARK Fentanyl II Assay</tradeName>
    <deviceName>ARK Fentanyl II 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5069-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:32.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030448</udiDi>
    <basicUdiDi>0858724003PGB0592C</basicUdiDi>
    <tradeName>ARK Pregabalin II Assay</tradeName>
    <deviceName>ARK Pregabalin II 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5059-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:30.930Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812101030004</udiDi>
    <basicUdiDi>0858724003KET0563D</basicUdiDi>
    <tradeName>ARK Ketamine Assay</tradeName>
    <deviceName>ARK Ketamine 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>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5056-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:25.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID4637</udiDi>
    <basicUdiDi>B-VID4637</basicUdiDi>
    <tradeName>Drug of Abuse Combo (MOP/MET/KET) Test Kit (FIA)</tradeName>
    <deviceName>Drug of Abuse Combo (MOP/MET/KET) Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID46-09-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:52.866Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID402T</udiDi>
    <basicUdiDi>B-VID402T</basicUdiDi>
    <tradeName>Tetrahydrocannabinol Test Kit (FIA)</tradeName>
    <deviceName>Tetrahydrocannabinol Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID40-09-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:47.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VID393A</udiDi>
    <basicUdiDi>B-VID393A</basicUdiDi>
    <tradeName>Ketamine Test Kit (FIA)</tradeName>
    <deviceName>Ketamine Test Kit (FIA)</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VID39-09-011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:22:46.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VDMEB-104DE</udiDi>
    <basicUdiDi>B-VDMEB-104DE</basicUdiDi>
    <tradeName>Meprobamate (MEB) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDMEB-104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:16:46.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VDMEB-102DA</udiDi>
    <basicUdiDi>B-VDMEB-102DA</basicUdiDi>
    <tradeName>Meprobamate (MEB) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDMEB-102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:16:45.762Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VDMDP-A104G7</udiDi>
    <basicUdiDi>B-VDMDP-A104G7</basicUdiDi>
    <tradeName>VivaDiag™ MDPHP Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDMDP-A104</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:16:40.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VDMEB-101D8</udiDi>
    <basicUdiDi>B-VDMEB-101D8</basicUdiDi>
    <tradeName>Meprobamate (MEB) Rapid Test</tradeName>
    <deviceName>Meprobamate (MEB) Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDMEB-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:16:40.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VDMDP-A102G3</udiDi>
    <basicUdiDi>B-VDMDP-A102G3</basicUdiDi>
    <tradeName>VivaDiag™ MDPHP Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDMDP-A102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:16:20.666Z</lastUpdated>
  </row>
</eudamedExport>