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<eudamedExport entity="devices">
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    <udiDi>07332940002282</udiDi>
    <basicUdiDi>B-07332940002282</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Bladder Cancer Monitor</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBLAD-CM-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:48.265Z</lastUpdated>
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  <row>
    <udiDi>07332940002268</udiDi>
    <basicUdiDi>B-07332940002268</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® Bladder Cancer Detection</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXBLAD-CD-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:55:45.786Z</lastUpdated>
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  <row>
    <udiDi>D-infogene_CP</udiDi>
    <basicUdiDi>B-infogene_CP</basicUdiDi>
    <tradeName>UROMONITOR</tradeName>
    <deviceName>UROMONITOR</deviceName>
    <manufacturerName>Infogene, Lda.</manufacturerName>
    <manufacturerSrn>PT-MF-000047847</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UROM01</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:54.537Z</lastUpdated>
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    <udiDi>D-A028D5</udiDi>
    <basicUdiDi>B-A028D5</basicUdiDi>
    <tradeName>INDICAID™ Bladder Cancer Mutation Gene Test (Urine, Gene sequencing technology)</tradeName>
    <deviceName>INDICAID™ Bladder Cancer Mutation Gene Test (Urine, Gene sequencing technology)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Bladder Cancer Mutation Gene Test (Urine, Gene sequencing technology)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:42.293Z</lastUpdated>
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  <row>
    <udiDi>D-A027D3</udiDi>
    <basicUdiDi>B-A027D3</basicUdiDi>
    <tradeName>INDICAID™ Bladder Cancer Methylation Test (Urine, Gene sequencing technology)</tradeName>
    <deviceName>INDICAID™ Bladder Cancer Methylation Test (Urine, Gene sequencing technology)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Bladder Cancer Methylation Test (Urine, Gene sequencing technology)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:41.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-A026CZ</udiDi>
    <basicUdiDi>B-A026CZ</basicUdiDi>
    <tradeName>INDICAID™ Bladder Cancer Methylation Test (Urine, PCR-fluorescence probe method)</tradeName>
    <deviceName>INDICAID™ Bladder Cancer Methylation Test (Urine, PCR-fluorescence probe method)</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ Bladder Cancer Methylation Test (Urine, PCR-fluorescence probe method)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:14:37.548Z</lastUpdated>
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  <row>
    <udiDi>06975585300026</udiDi>
    <basicUdiDi>B-06975585300026</basicUdiDi>
    <tradeName>06975585300026</tradeName>
    <deviceName>Early Diagnostic Kit for Urothelial Carcinoma (Reversible terminal termination method)</deviceName>
    <manufacturerName>Ankang Euler Technology Co., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000027199</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:39:54.690Z</lastUpdated>
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  <row>
    <udiDi>06975240820159</udiDi>
    <basicUdiDi>B-06975240820159</basicUdiDi>
    <tradeName>06975240820159</tradeName>
    <deviceName>UriFind® Bladder Cancer Assay Kit</deviceName>
    <manufacturerName>AnchorDx Medical Co.Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000054821</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40 Tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:23:58.113Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689627381</udiDi>
    <basicUdiDi>B-06974689627381</basicUdiDi>
    <tradeName>Urothelial carcinoma-associated gene methylation digital PCR detection kit</tradeName>
    <deviceName>Urothelial carcinoma-associated gene methylation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12918-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:28:17.156Z</lastUpdated>
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  <row>
    <udiDi>06974689627145</udiDi>
    <basicUdiDi>B-06974689627145</basicUdiDi>
    <tradeName>FGFR gene fusions and mutation digital PCR detection kit</tradeName>
    <deviceName>FGFR gene fusions and mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12585-2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:27:25.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974689626681</udiDi>
    <basicUdiDi>B-06974689626681</basicUdiDi>
    <tradeName>Urothelial carcinoma-associated gene methylation digital PCR detection kit</tradeName>
    <deviceName>Urothelial carcinoma-associated gene methylation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12918-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:26:28.153Z</lastUpdated>
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  <row>
    <udiDi>06974689626209</udiDi>
    <basicUdiDi>B-06974689626209</basicUdiDi>
    <tradeName>FGFR gene fusions and mutation digital PCR detection kit</tradeName>
    <deviceName>FGFR gene fusions and mutation digital PCR detection kit</deviceName>
    <manufacturerName>TargetingOne Technology (Beijing) Corporation</manufacturerName>
    <manufacturerSrn>CN-MF-000028247</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12585-1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:24:22.971Z</lastUpdated>
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  <row>
    <udiDi>06971532201699</udiDi>
    <basicUdiDi>B-06971532201699</basicUdiDi>
    <tradeName>06971532201699</tradeName>
    <deviceName>SOX1-OT and HIST1H4F Methylation Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-BCDNAm</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:58.928Z</lastUpdated>
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  <row>
    <udiDi>06971532201682</udiDi>
    <basicUdiDi>B-06971532201682</basicUdiDi>
    <tradeName>06971532201682</tradeName>
    <deviceName>SOX1-OT and HIST1H4F Methylation Real-time PCR Kit</deviceName>
    <manufacturerName>Guangzhou Hybribio Medicine Technology Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027677</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBRT-BCDNAm</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:59:58.706Z</lastUpdated>
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    <udiDi>8681957090164E6</udiDi>
    <basicUdiDi>8681957090164E6</basicUdiDi>
    <tradeName>FAST-APC Yeni Nesil Dizi Analizi ile APC Mutasyonlarını Saptama Kiti</tradeName>
    <deviceName>FAST-APC Yeni Nesil Dizi Analizi ile APC Mutasyonlarını Saptama Kiti</deviceName>
    <manufacturerName>MULTİGEN SAĞLIK HİZ. TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000050129</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M-APC-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:40:07.359Z</lastUpdated>
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