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<eudamedExport entity="devices">
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    <udiDi>08033803510409</udiDi>
    <basicUdiDi>803380351BCAAMIURAONE014X</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA ONE (9 Smp Pos) p/n 10750-00-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3310001210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:08:51.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510423</udiDi>
    <basicUdiDi>803380351BCAAMIURAONE014X</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA ONE (15 Smp Pos) p/n 10750-02-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3310001209</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:08:38.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803511406</udiDi>
    <basicUdiDi>803380351CVTACUVETTA6X5N9</basicUdiDi>
    <tradeName>Reading cuvettes Miura 200 pcs/pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:05:18.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803511413</udiDi>
    <basicUdiDi>803380351CVTACUVETTA6X5N9</basicUdiDi>
    <tradeName>Plate with Miura reading cuvettes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:04:28.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510010</udiDi>
    <basicUdiDi>803380351TUBASTOEXTR001Z5</basicUdiDi>
    <tradeName>Hemo One+, Universal stool extraction tubes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R3330000061</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:37:27.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510201</udiDi>
    <basicUdiDi>803380351BCAAM200DA0001YV</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 DA (31 Rgt Pos)  p/n 10997-00-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:15.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510225</udiDi>
    <basicUdiDi>803380351BCAAM200DA0001YV</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 DA (44 Rgt Pos)  p/n 10997-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:01.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510249</udiDi>
    <basicUdiDi>803380351BCAAM200SA000173</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 SA (31 Rgt Pos) p/n 11025-00-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001201-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:51.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510263</udiDi>
    <basicUdiDi>803380351BCAAM200SA000173</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA 200 SA (44 Rgt Pos) p/n 11025-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3320001202-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:51.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510362</udiDi>
    <basicUdiDi>803380351BCAAMIURADA001T4</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA DA (79 Smp Pos) p/n 10001-01-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3260011206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:49.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510386</udiDi>
    <basicUdiDi>803380351BCAAMIURADA001T4</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. MIURA DA (59 Smp Pos) p/n 10001-02-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3260011200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:57:47.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510195</udiDi>
    <basicUdiDi>803380351BCAAHEMOONE001PC</basicUdiDi>
    <tradeName>AUTOANALYZER MOD. HEMO ONE p/n 11154-10-A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I3330000001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:38:37.605Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510140</udiDi>
    <basicUdiDi>803380351SOLAEWCVTAL001HK</basicUdiDi>
    <tradeName>Soluzione Rinse NEW cvt per Miura 6x50ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000349</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:42:04.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510157</udiDi>
    <basicUdiDi>803380351SOLAEWCVTAL001HK</basicUdiDi>
    <tradeName>Soluzione Rinse NEW cvt per Miura 6x35ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000351</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:41:19.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510072</udiDi>
    <basicUdiDi>803380351SOLAMULTICLE10T2</basicUdiDi>
    <tradeName>Multiclean solution for Hemo One 1x1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000252</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T12:39:30.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510126</udiDi>
    <basicUdiDi>803380351SOLACLEANERAC029</basicUdiDi>
    <tradeName>Soluzione cleaner per Miura 2 Lt</tradeName>
    <deviceName>Soluzione cleaner per Miura</deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000335</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:14:02.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510102</udiDi>
    <basicUdiDi>803380351SOLACLEANERMA03X</basicUdiDi>
    <tradeName>Soluzione cleaner per Miura 2x100ml</tradeName>
    <deviceName>Soluzione cleaner per Miura 2x100ml</deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000282</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:58.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510058</udiDi>
    <basicUdiDi>803380351SOLAEWCVTAC001FL</basicUdiDi>
    <tradeName>Soluzione Rinse ew cvt per Miura 6x50ml</tradeName>
    <deviceName>Soluzione Rinse Ew Cvt per Miura</deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P3140000113</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:57.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510041</udiDi>
    <basicUdiDi>803380351SOLASYSTEM0001Y9</basicUdiDi>
    <tradeName>Soluzione sistemica Miura 2x1000ml</tradeName>
    <deviceName>Soluzione Sistemica</deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8033803510041</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:57.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033803510034</udiDi>
    <basicUdiDi>803380351SOLAEWPRBAC001DV</basicUdiDi>
    <tradeName>Hemo One+, Soluzione Rinse Ew Prb</tradeName>
    <deviceName>Rinse Ew Prb</deviceName>
    <manufacturerName>I.S.E. - SOCIETA' A RESPONSABILITA' LIMITATA - SISTEMI INTELLIGENTI ELETTRONICI</manufacturerName>
    <manufacturerSrn>IT-MF-000028898</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R3330000004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:13:56.221Z</lastUpdated>
  </row>
</eudamedExport>