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<eudamedExport entity="devices">
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    <udiDi>D-69717712013518M</udiDi>
    <basicUdiDi>B-69717712013518M</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Phencyclidine(PCP) 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-U11（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:58:18.683Z</lastUpdated>
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  <row>
    <udiDi>D-6909620WHDUSPCPMNUU</udiDi>
    <basicUdiDi>B-6909620WHDUSPCPMNUU</basicUdiDi>
    <tradeName>One-Step Drug of Abuse Test -Phencyclidine (PCP)</tradeName>
    <deviceName>Drugs of Abuse Tests (Phencyclidine)</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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WH-DU-S0x1101; WH-DU-S0x1102; WH-DU-S0x1103; WH-DU-S0x1104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:47:40.697Z</lastUpdated>
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  <row>
    <udiDi>D-GBPCP-102aHGZD</udiDi>
    <basicUdiDi>B-GBPCP-102aHGZD</basicUdiDi>
    <tradeName>One Step Phencyclidine Test Cassette (Urine)</tradeName>
    <deviceName>One Step Phencyclidine 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBPCP-102a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:20:19.535Z</lastUpdated>
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  <row>
    <udiDi>D-GBPCP-101aHGZ6</udiDi>
    <basicUdiDi>B-GBPCP-101aHGZ6</basicUdiDi>
    <tradeName>One Step Phencyclidine Test Strip (Urine)</tradeName>
    <deviceName>One Step Phencyclidine 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBPCP-101a</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:20:14.024Z</lastUpdated>
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  <row>
    <udiDi>08683548251732</udiDi>
    <basicUdiDi>B-08683548251732</basicUdiDi>
    <tradeName>DrugFor™ Phencyclidine (PCP) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDDOA25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:13:07.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683548251442</udiDi>
    <basicUdiDi>B-08683548251442</basicUdiDi>
    <tradeName>RapidFor™ Phencyclidine (PCP) Rapid Test Kit (Urine)</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDOA25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:12:23.719Z</lastUpdated>
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  <row>
    <udiDi>06976202761305</udiDi>
    <basicUdiDi>B-06976202761305</basicUdiDi>
    <tradeName>Phencyclidine (PCP) Rapid Test</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GDPCP-A102</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:33:36.610Z</lastUpdated>
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  <row>
    <udiDi>06974912094249</udiDi>
    <basicUdiDi>B-06974912094249</basicUdiDi>
    <tradeName>Phencyclidine (PCP) Rapid Test</tradeName>
    <deviceName>Phencyclidine (PCP) 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUPCP-C50</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:03:38.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>03532670100355</udiDi>
    <basicUdiDi>B-03532670100355</basicUdiDi>
    <tradeName>DRUGCHECK+ PCP</tradeName>
    <deviceName>DRUGCHECK+ PCP</deviceName>
    <manufacturerName>BIOSYNEX Swiss SA</manufacturerName>
    <manufacturerSrn>CH-MF-000024717</manufacturerSrn>
    <authorisedRepresentativeName>BIOSYNEX</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000014076</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1140011_SW</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:37:41.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581431248</udiDi>
    <basicUdiDi>B-06970581431248</basicUdiDi>
    <tradeName>Accu-Tell® PCP Cassette (Urine)</tradeName>
    <deviceName>Accu-Tell® PCP 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-B35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:45:14.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581431231</udiDi>
    <basicUdiDi>B-06970581431231</basicUdiDi>
    <tradeName>Accu-Tell® PCP Strip (Urine)</tradeName>
    <deviceName>Accu-Tell® PCP 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-A35</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:45:13.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970581431224</udiDi>
    <basicUdiDi>B-06970581431224</basicUdiDi>
    <tradeName>Accu-Tell® PCP Cassette (Saliva)</tradeName>
    <deviceName>Accu-Tell® PCP Cassette</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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-DOA-B173</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:45:12.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952999406155</udiDi>
    <basicUdiDi>B-06952999406155</basicUdiDi>
    <tradeName>06952999406155</tradeName>
    <deviceName>ABON™ Urine Test Drug Screen Cassette</deviceName>
    <manufacturerName>Abon Biopharm(Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000009171</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPC-102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T10:51:16.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816988</udiDi>
    <basicUdiDi>B-06952804816988</basicUdiDi>
    <tradeName>Phencyclidine Rapid Test</tradeName>
    <deviceName>Phencyclidine 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-U11, PCP-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:30:13.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06939663977746</udiDi>
    <basicUdiDi>B-06939663977746</basicUdiDi>
    <tradeName>One Step Phencyclidine Rapid Test (Urine)</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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip,Cassette,Panel,Cup</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:04:37.767Z</lastUpdated>
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  <row>
    <udiDi>06933260208203</udiDi>
    <basicUdiDi>B-06933260208203</basicUdiDi>
    <tradeName>Phencyclidine （PCP） Rapid Test（Urine）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012852</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BT0105301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T07:59:36.397Z</lastUpdated>
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  <row>
    <udiDi>04260658553853</udiDi>
    <basicUdiDi>B-04260658553853</basicUdiDi>
    <tradeName>Atlas</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.04.65.0.0020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:35:25.580Z</lastUpdated>
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