<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06950996090780</udiDi>
    <basicUdiDi>B-06950996090780</basicUdiDi>
    <tradeName>Fecal Occult Blood and Transferrin Combo Rapid Test Device (Feces)</tradeName>
    <deviceName>Fecal Occult Blood and Transferrin Combo Rapid Test Device (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFT-T606a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:29.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996071161</udiDi>
    <basicUdiDi>B-06950996071161</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Device (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Device (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-606b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:22.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996002448</udiDi>
    <basicUdiDi>B-06950996002448</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GEFOB-602b</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:31:37.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231494</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HE-02B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:16.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231487</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HE-01B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:14.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231470</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HE-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:12.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231463</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HE-01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:08.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231456</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HK-02B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:06.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231449</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HK-01B</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:05.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231432</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HK-02</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:22:02.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598231425</udiDi>
    <basicUdiDi>6970277510015EY7</basicUdiDi>
    <tradeName>Prostate- Specific Antigen (PSA) Rapid Test</tradeName>
    <deviceName>Prostate- Specific Antigen (PSA) Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TPS-NQ402HK-01</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:21:59.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598212493</udiDi>
    <basicUdiDi>B-06942598212493</basicUdiDi>
    <tradeName>DiaRapid CEA Rapid Test Cassette</tradeName>
    <deviceName>DiaRapid CEA Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCE-402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:20:04.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942598212486</udiDi>
    <basicUdiDi>B-06942598212486</basicUdiDi>
    <tradeName>DiaRapid AFP Rapid Test Cassette</tradeName>
    <deviceName>DiaRapid AFP Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAF-402</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-26T22:20:00.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339210166</udiDi>
    <basicUdiDi>B-06937339210166</basicUdiDi>
    <tradeName>FOB 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>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:57:59.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209559</udiDi>
    <basicUdiDi>B-06937339209559</basicUdiDi>
    <tradeName>AFP 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>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTAF-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:40.976Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339209528</udiDi>
    <basicUdiDi>B-06937339209528</basicUdiDi>
    <tradeName>CEA 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>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTCE-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:56:37.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>06937339203441</udiDi>
    <basicUdiDi>B-06937339203441</basicUdiDi>
    <tradeName>FOB 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>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTFO-U602</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:53:14.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020140676</udiDi>
    <basicUdiDi>B-06936020140676</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-02-20t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:10:17.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020140669</udiDi>
    <basicUdiDi>B-06936020140669</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-02-10t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:10:16.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020140652</udiDi>
    <basicUdiDi>B-06936020140652</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-02-5t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:10:14.955Z</lastUpdated>
  </row>
</eudamedExport>