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<eudamedExport entity="devices">
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    <udiDi>D-697177120137593</udiDi>
    <basicUdiDi>B-697177120137593</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) Rapid Test Device(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>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCA-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:25.383Z</lastUpdated>
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  <row>
    <udiDi>D-6909620WHDUSTCAMCT7</udiDi>
    <basicUdiDi>B-6909620WHDUSTCAMCT7</basicUdiDi>
    <tradeName>One-Step Drug of Abuse Test Tricyclic Antidepressants (TCA)</tradeName>
    <deviceName>Drugs of Abuse Tests (tricyclic antidepressants)</deviceName>
    <manufacturerName>W.H.P.M. Bioresearch &amp; Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003007</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-DU-S0x1201; WH-DU-S0x1202; WH-DU-S0x1203; WH-DU-S0x1204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:48:00.238Z</lastUpdated>
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  <row>
    <udiDi>D-nvm-620095SZ</udiDi>
    <basicUdiDi>B-nvm-620095SZ</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® TCA 1000 Test</tradeName>
    <deviceName>TCA 1000 Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620095</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:28:58.910Z</lastUpdated>
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  <row>
    <udiDi>D-nvm-102013PU</udiDi>
    <basicUdiDi>B-nvm-102013PU</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® TCA 1000 Test</tradeName>
    <deviceName>TCA 1000 Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:23:38.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-101013PM</udiDi>
    <basicUdiDi>B-nvm-101013PM</basicUdiDi>
    <tradeName>nal von minden Drug-Screen® TCA 1000 Test</tradeName>
    <deviceName>TCA 1000 Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:20:19.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBTCA-102aHGU4</udiDi>
    <basicUdiDi>B-GBTCA-102aHGU4</basicUdiDi>
    <tradeName>One Step Tricyclic Antidepressants Test Cassette (Urine)</tradeName>
    <deviceName>One Step Tricyclic Antidepressants Test Cassette (Urine)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBTCA-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:20:34.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GBTCA-101aHGTV</udiDi>
    <basicUdiDi>B-GBTCA-101aHGTV</basicUdiDi>
    <tradeName>One Step Tricyclic Antidepressants Test Strip (Urine)</tradeName>
    <deviceName>One Step Tricyclic Antidepressants Test Strip (Urine)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBTCA-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:20:33.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251756</udiDi>
    <basicUdiDi>B-08683548251756</basicUdiDi>
    <tradeName>DrugFor™ Tricyclic Antidepressants (TCA) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) 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>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA27</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:13:27.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251466</udiDi>
    <basicUdiDi>B-08683548251466</basicUdiDi>
    <tradeName>RapidFor™ Tricyclic Antidepressants (TCA) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) 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>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA27</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:12:22.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202761381</udiDi>
    <basicUdiDi>B-06976202761381</basicUdiDi>
    <tradeName>Tricyclic Antidepressants (TCA) Rapid Test</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) Rapid Test</deviceName>
    <manufacturerName>Zhejiang Greylynx Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032462</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDTCA-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:33:43.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974912094270</udiDi>
    <basicUdiDi>B-06974912094270</basicUdiDi>
    <tradeName>Tricyclic Antidepressants (TCA) Rapid Test</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) Rapid Test</deviceName>
    <manufacturerName>Nexlab Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047094</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUTCA-C50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:03:55.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958296</udiDi>
    <basicUdiDi>59026439BRT316JK</basicUdiDi>
    <tradeName>05902643958296</tradeName>
    <deviceName>Tricykl antydepres (TCA) kasetki 40 szt.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-316-K040</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T02:27:00.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581431262</udiDi>
    <basicUdiDi>B-06970581431262</basicUdiDi>
    <tradeName>Accu-Tell® TCA Cassette (Urine)</tradeName>
    <deviceName>Accu-Tell® TCA Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-B54</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:45:22.192Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581431255</udiDi>
    <basicUdiDi>B-06970581431255</basicUdiDi>
    <tradeName>Accu-Tell® TCA Strip (Urine)</tradeName>
    <deviceName>Accu-Tell® TCA Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-A54</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:45:16.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804817008</udiDi>
    <basicUdiDi>B-06952804817008</basicUdiDi>
    <tradeName>Tricyclic Antidepressant Rapid Test</tradeName>
    <deviceName>Tricyclic Antidepressant 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>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCA-U11 TCA-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:16.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663977753</udiDi>
    <basicUdiDi>B-06939663977753</basicUdiDi>
    <tradeName>One Step Tricyclic Antidepressants Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sejoy Biomedical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008447</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip,Cassette,Panel,Cup</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:38.958Z</lastUpdated>
  </row>
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    <udiDi>05902643958302</udiDi>
    <basicUdiDi>59026439BRT316JK</basicUdiDi>
    <tradeName>05902643958302</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-316-P050</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:11:30.453Z</lastUpdated>
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</eudamedExport>