<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00859110005111</udiDi>
    <basicUdiDi>B-00859110005111</basicUdiDi>
    <tradeName>VALIDATE® HEPARIN Test Set</tradeName>
    <deviceName>VALIDATE® HEPARIN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>903se</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:41.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005135</udiDi>
    <basicUdiDi>B-00859110005135</basicUdiDi>
    <tradeName>VALIDATE® FIBRINOGEN Test Set</tradeName>
    <deviceName>VALIDATE® FIBRINOGEN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>904st</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:39.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005128</udiDi>
    <basicUdiDi>B-00859110005128</basicUdiDi>
    <tradeName>VALIDATE® FIBRINOGEN Test Set</tradeName>
    <deviceName>VALIDATE® FIBRINOGEN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>904il</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:39.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005104</udiDi>
    <basicUdiDi>B-00859110005104</basicUdiDi>
    <tradeName>VALIDATE® HEPARIN Test Set</tradeName>
    <deviceName>VALIDATE® HEPARIN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>903st</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:25.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005098</udiDi>
    <basicUdiDi>B-00859110005098</basicUdiDi>
    <tradeName>VALIDATE® HEPARIN Test Set</tradeName>
    <deviceName>VALIDATE® HEPARIN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>903il</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:21.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005081</udiDi>
    <basicUdiDi>B-00859110005081</basicUdiDi>
    <tradeName>VALIDATE® D-DIMER Test Set</tradeName>
    <deviceName>VALIDATE® D-DIMER Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152002</emdnCode>
    <emdnDescription>HORMONE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902se</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:20.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005074</udiDi>
    <basicUdiDi>B-00859110005074</basicUdiDi>
    <tradeName>VALIDATE® D-DIMER Test Set</tradeName>
    <deviceName>VALIDATE® D-DIMER Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902st</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:19.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005067</udiDi>
    <basicUdiDi>B-00859110005067</basicUdiDi>
    <tradeName>VALIDATE® D-DIMER Test Set</tradeName>
    <deviceName>VALIDATE® D-DIMER Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902il</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:19.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005050</udiDi>
    <basicUdiDi>B-00859110005050</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301vt</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:15.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005043</udiDi>
    <basicUdiDi>B-00859110005043</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301ri</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:14.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005036</udiDi>
    <basicUdiDi>B-00859110005036</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301db</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:13.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005012</udiDi>
    <basicUdiDi>B-00859110005012</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301au</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:12.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859110005005</udiDi>
    <basicUdiDi>B-00859110005005</basicUdiDi>
    <tradeName>VALIDATE® TDM1 Test Set</tradeName>
    <deviceName>VALIDATE® TDM1 Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102152001</emdnCode>
    <emdnDescription>TDM/DRUG CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301ab</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:07.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>00856219002294</udiDi>
    <basicUdiDi>B-00856219002294</basicUdiDi>
    <tradeName>Stretta Catheter Kit</tradeName>
    <deviceName>Stretta Catheter</deviceName>
    <manufacturerName>Respiratory Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009086</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G0301010101</emdnCode>
    <emdnDescription>OESOPHAGEAL BALLOON CATHETERS, LOW PRESSURE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>175-5580</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:32:20.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>00856219002119</udiDi>
    <basicUdiDi>B-00856219002119</basicUdiDi>
    <tradeName>MDRF1 Generator &amp; Accessory Kit</tradeName>
    <deviceName>MDRF1 Generator Kit</deviceName>
    <manufacturerName>Respiratory Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009086</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mederi Radiofrequency Generator</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:32:17.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00856219002102</udiDi>
    <basicUdiDi>B-00856219002102</basicUdiDi>
    <tradeName>MDRF1 Generator</tradeName>
    <deviceName>MDRF1 Generator</deviceName>
    <manufacturerName>Respiratory Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000009086</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1899</emdnCode>
    <emdnDescription>ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Mederi Radiofrequency Generator</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:32:16.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245281</udiDi>
    <basicUdiDi>B-00850078245281</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Spotted Fever Rickettsia EIA IgG Antibody Kit</tradeName>
    <deviceName>Spotted Fever Rickettsia EIA IgG Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011705</emdnCode>
    <emdnDescription>RICKETTSIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFG-96K</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:10.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245274</udiDi>
    <basicUdiDi>B-00850078245274</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Typhus Group Rickettsia EIA IgM Antibody Kit</tradeName>
    <deviceName>Typhus Group Rickettsia EIA IgM Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011705</emdnCode>
    <emdnDescription>RICKETTSIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTM-96K</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:09.917Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245267</udiDi>
    <basicUdiDi>B-00850078245267</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Rickettsia typhi EIA IgG Antibody Kit</tradeName>
    <deviceName>Rickettsia typhi EIA IgG Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011705</emdnCode>
    <emdnDescription>RICKETTSIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTG-96K</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:05.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850078245250</udiDi>
    <basicUdiDi>B-00850078245250</basicUdiDi>
    <tradeName>Fuller Laboratories by VMRD Spotted Fever Rickettsia EIA IgM Antibody Kit</tradeName>
    <deviceName>Spotted Fever Rickettsia EIA IgM Antibody Kit</deviceName>
    <manufacturerName>VMRD, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000049394</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011705</emdnCode>
    <emdnDescription>RICKETTSIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RRM-96K</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:05:05.116Z</lastUpdated>
  </row>
</eudamedExport>