<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>*+G0561012701/ $$0100058XXXXXX*</udiDi>
    <basicUdiDi>++G0561012703E</basicUdiDi>
    <tradeName>vW Abnormal Control Plasma</tradeName>
    <deviceName>vW Abnormal Control Plasma</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101270</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:50.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561012691/ $$0100057XXXX7*</udiDi>
    <basicUdiDi>++G0561012693V</basicUdiDi>
    <tradeName>vW Normal Reference Plasma</tradeName>
    <deviceName>vW Normal Reference Plasma</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101269</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:50.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561012410/ $$0124065XXXX1*</udiDi>
    <basicUdiDi>++G05610124137</basicUdiDi>
    <tradeName>AggRecetin Reagent</tradeName>
    <deviceName>AggRecetin Reagent (Ristocetin A Sulfate)</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101241</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:45.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561009940/ $$0100022XXXXXZ*</udiDi>
    <basicUdiDi>++G0561009944Q</basicUdiDi>
    <tradeName>Sodium Citrate (0.11 M)</tradeName>
    <deviceName>Sodium Citrate (0.11 M)</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100994</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:44.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561009910/ $$0100137XXXXX$*</udiDi>
    <basicUdiDi>++G0561009914J</basicUdiDi>
    <tradeName>TRIS Buffered Saline</tradeName>
    <deviceName>TRIS Buffered Saline</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100991</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:43.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561009891/ $$0100025XXXXX%*</udiDi>
    <basicUdiDi>++G0561009894X</basicUdiDi>
    <tradeName>Calcium Chloride Solution (0.025 M)</tradeName>
    <deviceName>Calcium Chloride Solution (0.025 M)</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100989</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:42.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>*+G0561009700/ $$042603600562M*</udiDi>
    <basicUdiDi>++G0561009704A</basicUdiDi>
    <tradeName>AggRecetin Reagent</tradeName>
    <deviceName>AggRecetin Reagent (Ristocetin A Sulfate)</deviceName>
    <manufacturerName>Bio/Data Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000026991</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100970</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:18:38.874Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860006973537</udiDi>
    <basicUdiDi>B-00860006973537</basicUdiDi>
    <tradeName>AAV5 NAb Test</tradeName>
    <deviceName>AAV5 Neutralizing Antibody (NAb) Test</deviceName>
    <manufacturerName>Precision for Medicine, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007346</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC201301EU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:06.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142250502</udiDi>
    <basicUdiDi>85951422209407T</basicUdiDi>
    <tradeName>LOWY ROZTOK</tradeName>
    <deviceName>LOWY ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20940-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:21.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142243009</udiDi>
    <basicUdiDi>85951422201106A</basicUdiDi>
    <tradeName>KYSELINA PIKROVÁ nasycený vodný roztok</tradeName>
    <deviceName>KYSELINA PIKROVÁ nasycený vodný roztok</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20110-11000</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:56.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595142233413</udiDi>
    <basicUdiDi>85951422147107R</basicUdiDi>
    <tradeName>HAYEM ROZTOK</tradeName>
    <deviceName>HAYEM ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14710</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:46.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>08430155006084</udiDi>
    <basicUdiDi>8430155TURK75</basicUdiDi>
    <tradeName>TÜRK (1 x 500mL)</tradeName>
    <deviceName>TÜRK</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>996972</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:21:20.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>08430155005889</udiDi>
    <basicUdiDi>8430155HAYEMUR</basicUdiDi>
    <tradeName>HAYEM (1 x 500mL)</tradeName>
    <deviceName>HAYEM’S SOLUTION</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>991528</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:18:42.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798100043241</udiDi>
    <basicUdiDi>7798100041898552P5</basicUdiDi>
    <tradeName>Anticoagulante W</tradeName>
    <deviceName>Anticoagulante W</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>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1898552</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:09:13.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>07350145000001</udiDi>
    <basicUdiDi>73501450010011001SJ</basicUdiDi>
    <tradeName>Diluent CD</tradeName>
    <deviceName>Diluent CD</deviceName>
    <manufacturerName>Labex Reagens AB</manufacturerName>
    <manufacturerSrn>SE-MF-000048594</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI001</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:06:50.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870174</udiDi>
    <basicUdiDi>697982287CTCP0007GF</basicUdiDi>
    <tradeName>06979822870174</tradeName>
    <deviceName>Sample Separation Media</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTCP0007</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:21.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870167</udiDi>
    <basicUdiDi>697982287CTCP0006GD</basicUdiDi>
    <tradeName>06979822870167</tradeName>
    <deviceName>Sample Separation Media</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTCP0006</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:20.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06979822870082</udiDi>
    <basicUdiDi>697982287CTCP0003G7</basicUdiDi>
    <tradeName>06979822870082</tradeName>
    <deviceName>Sample Separation Media</deviceName>
    <manufacturerName>Cellomics (Shenzhen) Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000028334</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTCP0003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:47:05.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967224600</udiDi>
    <basicUdiDi>697326286000592A</basicUdiDi>
    <tradeName>06941967224600</tradeName>
    <deviceName>Lyse</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.31.03.03.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:45.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941967224594</udiDi>
    <basicUdiDi>6973262860005828</basicUdiDi>
    <tradeName>06941967224594</tradeName>
    <deviceName>Lyse</deviceName>
    <manufacturerName>Zybio Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000003349</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030199</emdnCode>
    <emdnDescription>HAEMATOLOGY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.09.31.03.02.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:24:44.970Z</lastUpdated>
  </row>
</eudamedExport>