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<eudamedExport entity="devices">
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    <udiDi>D-69717712016969S</udiDi>
    <basicUdiDi>B-69717712016969S</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Cotinine (COT) Rapid Test (Urine)</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COT-U21(25PCS)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:59:04.659Z</lastUpdated>
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  <row>
    <udiDi>D-GBCOT-102aZS</udiDi>
    <basicUdiDi>B-GBCOT-102aZS</basicUdiDi>
    <tradeName>One Step Cotinine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Cotinine 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBCOT-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:15:42.714Z</lastUpdated>
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  <row>
    <udiDi>D-DEMF000031456DSCCOTSB</udiDi>
    <basicUdiDi>B-DEMF000031456DSCCOTSB</basicUdiDi>
    <tradeName>SERATEC Cotinine Test</tradeName>
    <deviceName>SERATEC Cotinine Test</deviceName>
    <manufacturerName>SERATEC Gesellschaft für Biotechnologie mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000031456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSC-COT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T14:07:49.847Z</lastUpdated>
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  <row>
    <udiDi>08683548251619</udiDi>
    <basicUdiDi>B-08683548251619</basicUdiDi>
    <tradeName>DrugFor™ Cotinine (COT) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Cotinine (COT) Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:12:48.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251329</udiDi>
    <basicUdiDi>B-08683548251329</basicUdiDi>
    <tradeName>RapidFor™ Cotinine (COT) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Cotinine (COT) Rapid Test Kit (Urine)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA13</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:11:50.862Z</lastUpdated>
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  <row>
    <udiDi>06974566303544</udiDi>
    <basicUdiDi>B-06974566303544</basicUdiDi>
    <tradeName>Cotinine(COT)  Rapid Test</tradeName>
    <deviceName>Cotinine(COT)  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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCT-105</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:57:13.563Z</lastUpdated>
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  <row>
    <udiDi>06974473300742</udiDi>
    <basicUdiDi>B-06974473300742</basicUdiDi>
    <tradeName>COT Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>COT Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:04.712Z</lastUpdated>
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  <row>
    <udiDi>06974238910582</udiDi>
    <basicUdiDi>B-06974238910582</basicUdiDi>
    <tradeName>Cotinine (COT) Rapid Test (Saliva)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCOT050S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:10.185Z</lastUpdated>
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  <row>
    <udiDi>06974238910544</udiDi>
    <basicUdiDi>B-06974238910544</basicUdiDi>
    <tradeName>Cotinine (COT) Rapid Test (Saliva)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCOT050S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:04.704Z</lastUpdated>
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  <row>
    <udiDi>00884883012905</udiDi>
    <basicUdiDi>B-00884883012905</basicUdiDi>
    <tradeName>00884883012905</tradeName>
    <deviceName>DRI Cotinine 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10018516</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:32:21.647Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883002876</udiDi>
    <basicUdiDi>B-00884883002876</basicUdiDi>
    <tradeName>00884883002876</tradeName>
    <deviceName>DRI Cotinine 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0395</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:15:30.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001084</udiDi>
    <basicUdiDi>B-00884883001084</basicUdiDi>
    <tradeName>00884883001084</tradeName>
    <deviceName>DRI Cotinine High 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0470</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:48.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884883001060</udiDi>
    <basicUdiDi>B-00884883001060</basicUdiDi>
    <tradeName>00884883001060</tradeName>
    <deviceName>DRI Cotinine 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:46.550Z</lastUpdated>
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  <row>
    <udiDi>00884883001077</udiDi>
    <basicUdiDi>B-00884883001077</basicUdiDi>
    <tradeName>00884883001077</tradeName>
    <deviceName>DRI Cotinine Low 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:44.129Z</lastUpdated>
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  <row>
    <udiDi>00884883001053</udiDi>
    <basicUdiDi>B-00884883001053</basicUdiDi>
    <tradeName>00884883001053</tradeName>
    <deviceName>DRI Cotinine 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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0394</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:41.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817022</udiDi>
    <basicUdiDi>B-06952804817022</basicUdiDi>
    <tradeName>Cotinine Rapid Test</tradeName>
    <deviceName>Cotinine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COT-U11, COT-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:19.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293581627</udiDi>
    <basicUdiDi>697518250G127263H</basicUdiDi>
    <tradeName>Cotinine Panel Test Drugs of Abuse Test Kit</tradeName>
    <deviceName>Cotinine Panel Test Drugs of Abuse Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G12726</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:26:12.617Z</lastUpdated>
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</eudamedExport>