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<eudamedExport entity="devices">
  <row>
    <udiDi>06977194141502</udiDi>
    <basicUdiDi>B-06977194141502</basicUdiDi>
    <tradeName>06977194141502</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0503002</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:39.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977194141496</udiDi>
    <basicUdiDi>B-06977194141496</basicUdiDi>
    <tradeName>06977194141496</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen BioRay Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045502</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HR0503001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:38.324Z</lastUpdated>
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  <row>
    <udiDi>06976374752842</udiDi>
    <basicUdiDi>B-06976374752842</basicUdiDi>
    <tradeName>Human Epididymis Protein 4（HE4）TestKit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Human Epididymis Protein 4（HE4）TestKit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR068-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:08.172Z</lastUpdated>
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  <row>
    <udiDi>06976374752835</udiDi>
    <basicUdiDi>B-06976374752835</basicUdiDi>
    <tradeName>Carbohydrate Antigen 72-4（CA72-4）Test Kit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Carbohydrate Antigen 72-4（CA72-4）Test Kit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR071-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:47:07.353Z</lastUpdated>
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  <row>
    <udiDi>06976374752279</udiDi>
    <basicUdiDi>B-06976374752279</basicUdiDi>
    <tradeName>Fecal Occult Blood （FOB）TestTest Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood （FOB）TestTest Kit (Colloidal Gold)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests / kit（DR098-4）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:38.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752262</udiDi>
    <basicUdiDi>B-06976374752262</basicUdiDi>
    <tradeName>Fecal Occult Blood （FOB）TestTest Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood （FOB）TestTest Kit (Colloidal Gold)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR098-3）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:38.146Z</lastUpdated>
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  <row>
    <udiDi>06976374752132</udiDi>
    <basicUdiDi>B-06976374752132</basicUdiDi>
    <tradeName>Free Prostate Specific Antigen (f-PSA) Detection Kit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Free Prostate Specific Antigen (f-PSA) Detection Kit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR080-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:14.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374752125</udiDi>
    <basicUdiDi>B-06976374752125</basicUdiDi>
    <tradeName>Total Prostate Specific Antigen (t-PSA) Detection Kit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Total Prostate Specific Antigen (t-PSA) Detection Kit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR079-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:14.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374751845</udiDi>
    <basicUdiDi>B-06976374751845</basicUdiDi>
    <tradeName>Carbohydrate Antigen 15-3 (CA15-3) TestKit （Fluorescence immunochromatography method）</tradeName>
    <deviceName>Carbohydrate Antigen 15-3 (CA15-3) TestKit （Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR069-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:07.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374751906</udiDi>
    <basicUdiDi>B-06976374751906</basicUdiDi>
    <tradeName>Carbohydrate Antigen 19-9 (CA19-9) Test Kit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Carbohydrate Antigen 19-9 (CA19-9) Test Kit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR070-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:06.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374751784</udiDi>
    <basicUdiDi>B-06976374751784</basicUdiDi>
    <tradeName>Carbohydrate Antigen 125（CA125）TestKit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Carbohydrate Antigen 125（CA125）TestKit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR067-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:06.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374751722</udiDi>
    <basicUdiDi>B-06976374751722</basicUdiDi>
    <tradeName>Alpha Fetoprotein (AFP)TestKit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Alpha Fetoprotein (AFP)TestKit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR066-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:04.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976374751661</udiDi>
    <basicUdiDi>B-06976374751661</basicUdiDi>
    <tradeName>Carcinoembryonic Antigen (CEA) TestKit（Fluorescence immunochromatography method）</tradeName>
    <deviceName>Carcinoembryonic Antigen (CEA) TestKit（Fluorescence immunochromatography method）</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20 tests / kit（DR065-2）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:43:01.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762432</udiDi>
    <basicUdiDi>B-06976202762432</basicUdiDi>
    <tradeName>CEA Rapid Test</tradeName>
    <deviceName>CEA 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>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTCEA-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:37:08.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976202762371</udiDi>
    <basicUdiDi>B-06976202762371</basicUdiDi>
    <tradeName>AFP Rapid Test</tradeName>
    <deviceName>AFP 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>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTAFP-402</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:36:59.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424225916</udiDi>
    <basicUdiDi>B-06975424225916</basicUdiDi>
    <tradeName>PSA Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>PSA Assay Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248601C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:44:20.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424223516</udiDi>
    <basicUdiDi>B-06975424223516</basicUdiDi>
    <tradeName>PSA Assay Kit  (Fluorescence Immunoassay)</tradeName>
    <deviceName>PSA Assay Kit  (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>DiYaLab ZJG Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000048648</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL248601</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:39:26.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068491319</udiDi>
    <basicUdiDi>B-06975068491319</basicUdiDi>
    <tradeName>Fecal Occult Blood/Transferrin（FOB/TRF）Combined Test Kit（Colloidal Gold）</tradeName>
    <deviceName>Fecal Occult Blood/Transferrin（FOB/TRF）Combined Test Kit（Colloidal Gold）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</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>CP076.B2</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:32:26.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490718</udiDi>
    <basicUdiDi>B-06975068490718</basicUdiDi>
    <tradeName>Alpha Fetoprotein（AFP）Rapid Quantitative Test（Fluorescence immunoassay）</tradeName>
    <deviceName>Alpha Fetoprotein（AFP）Rapid Quantitative Test（Fluorescence immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP048.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:31:51.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975068490428</udiDi>
    <basicUdiDi>B-06975068490428</basicUdiDi>
    <tradeName>Fecal Occult Blood/Transferrin（FOB/TRF）Combined Test Kit（Immunochromatographic Assay）</tradeName>
    <deviceName>Fecal Occult Blood/Transferrin（FOB/TRF）Combined Test Kit（Immunochromatographic Assay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</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>CP026.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:30:54.088Z</lastUpdated>
  </row>
</eudamedExport>