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<eudamedExport entity="devices">
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    <udiDi>06975578360204</udiDi>
    <basicUdiDi>B-06975578360204</basicUdiDi>
    <tradeName>06975578360204</tradeName>
    <deviceName>Four Bacteria Combined Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000265</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:14.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975578360198</udiDi>
    <basicUdiDi>B-06975578360198</basicUdiDi>
    <tradeName>06975578360198</tradeName>
    <deviceName>Five Streptococcus Species Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070202</emdnCode>
    <emdnDescription>BLOOD STREAM INFECTION/SEPSIS (BACTERIA &amp; FUNGI) - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000264</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:12.183Z</lastUpdated>
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  <row>
    <udiDi>06975578360181</udiDi>
    <basicUdiDi>B-06975578360181</basicUdiDi>
    <tradeName>06975578360181</tradeName>
    <deviceName>Bloodstream Infection Pathogen and Antimicrobial Resistance Gene Nucleic Acid Detection Kit　(Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000263</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:10.586Z</lastUpdated>
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  <row>
    <udiDi>06975578360167</udiDi>
    <basicUdiDi>B-06975578360167</basicUdiDi>
    <tradeName>06975578360167</tradeName>
    <deviceName>Six Candida Species Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070201</emdnCode>
    <emdnDescription>GRAM+ - GRAM- - FUNGI - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000261</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:09.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975578360150</udiDi>
    <basicUdiDi>B-06975578360150</basicUdiDi>
    <tradeName>06975578360150</tradeName>
    <deviceName>Invasive Fungal Nucleic Acid Detection Kit (Digital PCR Method)</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000244</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:08.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975578360143</udiDi>
    <basicUdiDi>B-06975578360143</basicUdiDi>
    <tradeName>06975578360143</tradeName>
    <deviceName>Twenty Bloodstream Pathogenic Microorganisms and Drug Resistance Genes Detection Kit (Digital PCR Method）</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070599</emdnCode>
    <emdnDescription>MULTIPLE INFECTIOUS - MULTIPLEX ASSAYS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000236</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:05.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975578360129</udiDi>
    <basicUdiDi>B-06975578360129</basicUdiDi>
    <tradeName>06975578360129</tradeName>
    <deviceName>PilotTM Encephalitis /Meningitis Digital PCR Kit</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070505</emdnCode>
    <emdnDescription>MENINGITIS / ENCEPHALITIS INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000266</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:04.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76466GD</udiDi>
    <basicUdiDi>B-DC76466GD</basicUdiDi>
    <tradeName>iStar-Calcitonin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76465</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:57:25.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DC76467GF</udiDi>
    <basicUdiDi>B-DC76467GF</basicUdiDi>
    <tradeName>iStar-Calcitonin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76467</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:57:25.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358886115</udiDi>
    <basicUdiDi>B-06975358886115</basicUdiDi>
    <tradeName>PCR-CE α/β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α/β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:01.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358886108</udiDi>
    <basicUdiDi>B-06975358886108</basicUdiDi>
    <tradeName>PCR-CE α/β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α/β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:30:00.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358886016</udiDi>
    <basicUdiDi>B-06975358886016</basicUdiDi>
    <tradeName>PCR-CE β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:59.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358886009</udiDi>
    <basicUdiDi>B-06975358886009</basicUdiDi>
    <tradeName>PCR-CE β-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE β-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:55.606Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885910</udiDi>
    <basicUdiDi>B-06975358885910</basicUdiDi>
    <tradeName>PCR-CE α-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:54.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885903</udiDi>
    <basicUdiDi>B-06975358885903</basicUdiDi>
    <tradeName>PCR-CE α-Thalassemia Kit</tradeName>
    <deviceName>PCR-CE α-Thalassemia Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:54.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885811</udiDi>
    <basicUdiDi>B-06975358885811</basicUdiDi>
    <tradeName>PCR-CE NOTCH2NLC Kit</tradeName>
    <deviceName>PCR-CE NOTCH2NLC Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:53.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975358885804</udiDi>
    <basicUdiDi>B-06975358885804</basicUdiDi>
    <tradeName>PCR-CE NOTCH2NLC Kit</tradeName>
    <deviceName>PCR-CE NOTCH2NLC Kit</deviceName>
    <manufacturerName>Xiamen Biofast Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027220</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04110016</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:29:49.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975327120653</udiDi>
    <basicUdiDi>B-06975327120653</basicUdiDi>
    <tradeName>MiniDock MTB Test</tradeName>
    <deviceName>MTB Nucleic Acid Test Card</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010703</emdnCode>
    <emdnDescription>MYCOBACTERIAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RM1012202-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:44.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975327120592</udiDi>
    <basicUdiDi>B-06975327120592</basicUdiDi>
    <tradeName>06975327120592</tradeName>
    <deviceName>SARS-CoV-2/Influenza A/Influenza B/RSV Nucleic Acid Test Card</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070302</emdnCode>
    <emdnDescription>OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RM1011702-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:44.137Z</lastUpdated>
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    <udiDi>06975327120479</udiDi>
    <basicUdiDi>B-06975327120479</basicUdiDi>
    <tradeName>06975327120479</tradeName>
    <deviceName>Mycobacterium Tuberculosis Nucleic Acid Assay Control</deviceName>
    <manufacturerName>Guangzhou Pluslife Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000025784</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRM1010602-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:28:43.339Z</lastUpdated>
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