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<eudamedExport entity="devices">
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    <udiDi>05056013025832</udiDi>
    <basicUdiDi>505601300CEIFEDIL3S</basicUdiDi>
    <tradeName>UltraCE IFE Diluent</tradeName>
    <deviceName>UltraCE IFE Diluent</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8150</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:32.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025818</udiDi>
    <basicUdiDi>505601300ULTCEURPREPXK</basicUdiDi>
    <tradeName>UltraCE Urine Prep</tradeName>
    <deviceName>UltraCE Urine Prep</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V130</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:27.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025764</udiDi>
    <basicUdiDi>505601300ULTCEBUFS5Z</basicUdiDi>
    <tradeName>UltraCE Maintenance Buffer</tradeName>
    <deviceName>CE Maintenance and Storage Buffers</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:09.265Z</lastUpdated>
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  <row>
    <udiDi>05056013025757</udiDi>
    <basicUdiDi>505601300V8ULTRACE3Z</basicUdiDi>
    <tradeName>V8 UltraCE</tradeName>
    <deviceName>V8 UltraCE</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V801</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:08.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025771</udiDi>
    <basicUdiDi>505601300ULTCEBUFS5Z</basicUdiDi>
    <tradeName>UltraCE Storage Buffer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8020</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-20T08:27:18.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SL-25-IFIXNF</udiDi>
    <basicUdiDi>B-SL-25-IFIXNF</basicUdiDi>
    <tradeName>D-SL-25-IFIXNF</tradeName>
    <deviceName>Immunofixation electrophoresis kit 25 tests</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-25-IFIX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:33.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SELVET242D</udiDi>
    <basicUdiDi>B-SELVET242D</basicUdiDi>
    <tradeName>D-SELVET242D</tradeName>
    <deviceName>Selvet 24</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLV24</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:13:30.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MINIPHORTS55</udiDi>
    <basicUdiDi>B-MINIPHORTS55</basicUdiDi>
    <tradeName>D-MINIPHORTS55</tradeName>
    <deviceName>Miniphor TS</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MNFTS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:45.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MINIPHOR08Y5</udiDi>
    <basicUdiDi>B-MINIPHOR08Y5</basicUdiDi>
    <tradeName>D-MINIPHOR08Y5</tradeName>
    <deviceName>Miniphor 08</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MNF08</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:07:44.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ADALYA40IFE3U</udiDi>
    <basicUdiDi>B-ADALYA40IFE3U</basicUdiDi>
    <tradeName>D-ADALYA40IFE3U</tradeName>
    <deviceName>Adalya 40 IFE</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADL40IFX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:42.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ADALYA40GH</udiDi>
    <basicUdiDi>B-ADALYA40GH</basicUdiDi>
    <tradeName>D-ADALYA40GH</tradeName>
    <deviceName>Adalya 40</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADL40</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:28:41.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435491999878</udiDi>
    <basicUdiDi>84354919SCANION01RL</basicUdiDi>
    <tradeName>SCANION</tradeName>
    <deviceName>SCANION</deviceName>
    <manufacturerName>RAL TECNICA PARA EL LABORATORIO, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000306</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RA420000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:07:54.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>80588943000296</udiDi>
    <basicUdiDi>805889430FE26G6</basicUdiDi>
    <tradeName>FE26 Electrophoresis Analyzer</tradeName>
    <deviceName>FE26 Electrophoresis Analyzer</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FE26</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:18:51.768Z</lastUpdated>
  </row>
</eudamedExport>