<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033891324230</udiDi>
    <basicUdiDi>803389132VESMATIC5008M</basicUdiDi>
    <tradeName>VES-MATIC 5</tradeName>
    <deviceName>VES-MATIC 5</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10360</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:38.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891324551</udiDi>
    <basicUdiDi>803389132VMORIGINAL00NX</basicUdiDi>
    <tradeName>VES MATIC Original</tradeName>
    <deviceName>VES MATIC ORIGINAL</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10340</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:19:36.551Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033891322069</udiDi>
    <basicUdiDi>803389132CUBE30T00V6</basicUdiDi>
    <tradeName>CUBE 30 TOUCH</tradeName>
    <deviceName>CUBE 30 TOUCH</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10395</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:18:54.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>07791778038748</udiDi>
    <basicUdiDi>7791778W020290019351058ZP</basicUdiDi>
    <tradeName>e32</tradeName>
    <deviceName>e32</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9351058</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:47.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978507780197</udiDi>
    <basicUdiDi>697850778ESR10TB</basicUdiDi>
    <tradeName>ESR Analyzer</tradeName>
    <deviceName>ESR Analyzer</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048840</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN0127</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:37:29.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975488440041</udiDi>
    <basicUdiDi>697548844ESR22SU</basicUdiDi>
    <tradeName>ESR Analyzer</tradeName>
    <deviceName>ESR Analyzer</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040107</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESRA-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:07:38.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896406002874</udiDi>
    <basicUdiDi>0896406002miniiSEDSD</basicUdiDi>
    <tradeName>miniiSED</tradeName>
    <deviceName>miniiSED Automated ESR Analyzer</deviceName>
    <manufacturerName>Alcor Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000029295</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112-01017</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:01:31.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896406002508</udiDi>
    <basicUdiDi>0896406002iSED2Elite5D</basicUdiDi>
    <tradeName>iSED</tradeName>
    <deviceName>iSED Automated ESR Analyzer</deviceName>
    <manufacturerName>Alcor Scientific</manufacturerName>
    <manufacturerSrn>US-MF-000029295</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>112-00101</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:01:30.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302940</udiDi>
    <basicUdiDi>6936895BS01227</basicUdiDi>
    <tradeName>Auto ESR Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-ESR40pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:44.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302957</udiDi>
    <basicUdiDi>6936895BS01227</basicUdiDi>
    <tradeName>Auto ESR Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-ESR20pro</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:44.517Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895302964</udiDi>
    <basicUdiDi>6936895BS01227</basicUdiDi>
    <tradeName>Auto ESR Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-ESR20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:44.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895304609</udiDi>
    <basicUdiDi>6936895BS01227</basicUdiDi>
    <tradeName>Auto ESR Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-ESR20E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:17:42.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889002209</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:30.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001226</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780225</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:30.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001233</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780226</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:29.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889002247</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1780250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:25.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001844</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1740100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:06.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>18429889001141</udiDi>
    <basicUdiDi>8429889-TF-2000-M2</basicUdiDi>
    <tradeName>Erythrocyte Sedimentation Rate Devices (ESR)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AQUISEL S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000020750</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02029001</emdnCode>
    <emdnDescription>ERYTHROCYTE SEDIMENTATION RATE DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1760200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:03:05.204Z</lastUpdated>
  </row>
</eudamedExport>