<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <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>2026-07-01T22:48:02.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025825</udiDi>
    <basicUdiDi>505601300ULTCEIDCG</basicUdiDi>
    <tradeName>UltraCE Immunodisplacement</tradeName>
    <deviceName>UltraCE Immunodisplacement</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010110</emdnCode>
    <emdnDescription>IMMUNOELECTROPHORESIS KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8140</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:48:01.324Z</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>2026-07-01T22:48:00.563Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025801</udiDi>
    <basicUdiDi>505601300ULTCEIDCONTKN</basicUdiDi>
    <tradeName>Immunotyping Control</tradeName>
    <deviceName>Immunotyping Control</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V150</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:59.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025788</udiDi>
    <basicUdiDi>505601300ULTCESPCONTTU</basicUdiDi>
    <tradeName>Serum Protein Normal Control</tradeName>
    <deviceName>CE Serum Protein Controls</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V110</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:58.938Z</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>2026-07-01T22:47:58.148Z</lastUpdated>
  </row>
  <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>2026-07-01T22:47:57.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025689</udiDi>
    <basicUdiDi>505601300ULTCESPE6</basicUdiDi>
    <tradeName>UltraCE Serum Protein</tradeName>
    <deviceName>UltraCE Serum Protein</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:56.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013016557</udiDi>
    <basicUdiDi>505601300PTMR</basicUdiDi>
    <tradeName>Thromboplastin L</tradeName>
    <deviceName>Thromboplastin L</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5265L</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:55.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013007944</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>SAS-MX SP-10 Kit</tradeName>
    <deviceName>Serum Protein Kits</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100100</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:54.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013025795</udiDi>
    <basicUdiDi>505601300ULTCESPCONTTU</basicUdiDi>
    <tradeName>Serum Protein Abnormal Control</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:00:05.257Z</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>2026-06-19T10:00:02.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013017424</udiDi>
    <basicUdiDi>505601300PTMR</basicUdiDi>
    <tradeName>Thromboplastin L</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5265HL</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:57.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013016779</udiDi>
    <basicUdiDi>505601300PTMR</basicUdiDi>
    <tradeName>Thromboplastin L</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5267L</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:56.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013011569</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>REP/SPIFE SP 180 Kit</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3147</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:53.533Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013011552</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>REP/SPIFE SP 300 Kit</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3146</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:51.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013011538</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>REP/SPIFE SP 600 Kit</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>3145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:50.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013010517</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>SAS-3 SP-60 Kit</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300100</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:50.046Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013009245</udiDi>
    <basicUdiDi>B-05056013009245</basicUdiDi>
    <tradeName>SAS-1 Cholesterol Profile Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010205</emdnCode>
    <emdnDescription>CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:48.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056013009009</udiDi>
    <basicUdiDi>5056013005BANDM8</basicUdiDi>
    <tradeName>SAS-1 SP-24 Kit</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 C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>200100H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T09:59:39.305Z</lastUpdated>
  </row>
</eudamedExport>