<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810143500004</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Ankle Left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE KNEE-ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL050-000-L1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500011</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Ankle Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PASSIVE ANKLE-FOOT ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL050-000-R1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500028</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Pro/Sup, Long, Left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL060-00L-L1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500035</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Pro/Sup, Long, Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL060-00L-R1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500042</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Elbow Left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL100-000-L1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.759Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500059</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Elbow Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL100-000-R1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500110</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Pro/Sup, Short, Left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL060-00M-L1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500127</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Pro/Sup, Short, Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL060-00M-R1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500134</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Knee Extension Left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL200-000-L0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500141</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Knee Extension Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL200-000-R0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500165</udiDi>
    <basicUdiDi>081014350GLK8</basicUdiDi>
    <tradeName>JAS GL Knee, Flexion, Slotted</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>KNEE ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GL20FX-000-S1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810143500769</udiDi>
    <basicUdiDi>081014350AdvanceYE</basicUdiDi>
    <tradeName>JAS Advance Elbow Flexion Dynamic Device, Right</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Joint Active Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000045774</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ELBOW ORTHOSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>199086-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:10.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025525602</udiDi>
    <basicUdiDi>856492005SupportCathKP</basicUdiDi>
    <tradeName>Wingman</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Reflow Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017521</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WGM35090CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:40:30.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850025525619</udiDi>
    <basicUdiDi>856492005SupportCathKP</basicUdiDi>
    <tradeName>Wingman</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Reflow Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017521</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WGM35135CE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T19:40:08.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860006589721</udiDi>
    <basicUdiDi>B-00860006589721</basicUdiDi>
    <tradeName>ACCURUN Anti-SARS-CoV-2 IgM Controls Kit</tradeName>
    <deviceName>ACCURUN Anti-SARS-CoV-2 IgM Controls Kit</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080804</emdnCode>
    <emdnDescription>OTHER VIROLOGY CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2015-0232</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:06.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860006589707</udiDi>
    <basicUdiDi>B-00860006589707</basicUdiDi>
    <tradeName>A21 Series 1000 CE</tradeName>
    <deviceName>A21 Series 1000 CE</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016356</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080807</emdnCode>
    <emdnDescription>MULTICONSTITUENT CONTROLS - INF.IMM.</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000-0028</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:05.235Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860000470018</udiDi>
    <basicUdiDi>B-00860000470018</basicUdiDi>
    <tradeName>EyeArt</tradeName>
    <deviceName>EyeArt</deviceName>
    <manufacturerName>Eyenuk, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000004180</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120192</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2.1.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:47.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859261006258</udiDi>
    <basicUdiDi>B-00859261006258</basicUdiDi>
    <tradeName>ViewSite Brain Access System</tradeName>
    <deviceName>ViewSite Brain Access System (VBAS)</deviceName>
    <manufacturerName>Vycor Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007171</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC120803AC</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:11.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859261006241</udiDi>
    <basicUdiDi>B-00859261006241</basicUdiDi>
    <tradeName>ViewSite Brain Access System</tradeName>
    <deviceName>ViewSite Brain Access System</deviceName>
    <manufacturerName>Vycor Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007171</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC120805AC</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:10.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859261006234</udiDi>
    <basicUdiDi>B-00859261006234</basicUdiDi>
    <tradeName>ViewSite Brain Access System</tradeName>
    <deviceName>ViewSite Brain Access System (VBAS) TC120807AC</deviceName>
    <manufacturerName>Vycor Medical Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000007171</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC120807AC</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:09.847Z</lastUpdated>
  </row>
</eudamedExport>