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<eudamedExport entity="devices">
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    <udiDi>01230000006187</udiDi>
    <basicUdiDi>B-01230000006187</basicUdiDi>
    <tradeName>01230000006187</tradeName>
    <deviceName>ECOS-300CY</deviceName>
    <manufacturerName>CytoSorbents Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002213</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0061</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:06:52.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>01230000006149</udiDi>
    <basicUdiDi>B-01230000006149</basicUdiDi>
    <tradeName>01230000006149</tradeName>
    <deviceName>PerSorb for PerLife</deviceName>
    <manufacturerName>CytoSorbents Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002213</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0231</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:06:52.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>01230000006002</udiDi>
    <basicUdiDi>B-01230000006002</basicUdiDi>
    <tradeName>CytoSorb 300</tradeName>
    <deviceName>CytoSorb 300 mL Device</deviceName>
    <manufacturerName>CytoSorbents Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002213</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>F010702</emdnCode>
    <emdnDescription>HAEMOPERFUSION RESIN FILTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30-0031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:06:51.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>00863788000446</udiDi>
    <basicUdiDi>B-00863788000446</basicUdiDi>
    <tradeName>IASD System II</tradeName>
    <deviceName>IASD System II</deviceName>
    <manufacturerName>Corvia Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024255</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0799</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00261</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:59.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00862468000332</udiDi>
    <basicUdiDi>B-00862468000332</basicUdiDi>
    <tradeName>Peregrine System Infusion Catheter</tradeName>
    <deviceName>Peregrine System Infusion Catheter (3-4mm)</deviceName>
    <manufacturerName>Ablative Solutions Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002880</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020205</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FG32109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:38.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00862468000301</udiDi>
    <basicUdiDi>B-00862468000301</basicUdiDi>
    <tradeName>Peregrine System Infusion Catheter</tradeName>
    <deviceName>Peregrine System Infusion Catheter (4-7mm)</deviceName>
    <manufacturerName>Ablative Solutions Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002880</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0104020205</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>FG32103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:34.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861841000204</udiDi>
    <basicUdiDi>B-00861841000204</basicUdiDi>
    <tradeName>SIRA-1000</tradeName>
    <deviceName>SIRA RFA Electrosurgical Device</deviceName>
    <manufacturerName>Innoblative Designs, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044282</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K02010199</emdnCode>
    <emdnDescription>MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2050240</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:11.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861539000189</udiDi>
    <basicUdiDi>B-00861539000189</basicUdiDi>
    <tradeName>00861539000189</tradeName>
    <deviceName>MECTA Sigma 200 J</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-5001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:05.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861539000172</udiDi>
    <basicUdiDi>B-00861539000172</basicUdiDi>
    <tradeName>00861539000172</tradeName>
    <deviceName>spECTrum 5000CEM</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3024</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:48:04.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861539000165</udiDi>
    <basicUdiDi>B-00861539000165</basicUdiDi>
    <tradeName>00861539000165</tradeName>
    <deviceName>spECTrum 4000CEQ</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3027</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:46:01.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861539000158</udiDi>
    <basicUdiDi>B-00861539000158</basicUdiDi>
    <tradeName>00861539000158</tradeName>
    <deviceName>spECTrum 4000CEM</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3026</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:59.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>00861539000141</udiDi>
    <basicUdiDi>B-00861539000141</basicUdiDi>
    <tradeName>00861539000141</tradeName>
    <deviceName>spECTrum 5000CEQ</deviceName>
    <manufacturerName>MECTA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000019538</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109002</emdnCode>
    <emdnDescription>ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>9438-3025</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:45:58.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859389005225</udiDi>
    <basicUdiDi>B-00859389005225</basicUdiDi>
    <tradeName>ProxiCor for Cardiac Tissue Repair</tradeName>
    <deviceName>ProxiCor for Cardiac Tissue Repair, Single Pack, 4 cm X 7 cm, OUS</deviceName>
    <manufacturerName>Aziyo Biologics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003634</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900399</emdnCode>
    <emdnDescription>TISSUE PATCHES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCV-120-404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:44.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859389005218</udiDi>
    <basicUdiDi>B-00859389005218</basicUdiDi>
    <tradeName>ProxiCor for Cardiac Tissue Repair</tradeName>
    <deviceName>ProxiCor for Cardiac Tissue Repair, Single Pack, 7 cm X 10 cm, OUS</deviceName>
    <manufacturerName>Aziyo Biologics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003634</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P900399</emdnCode>
    <emdnDescription>TISSUE PATCHES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCV-120-401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:29.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859389005201</udiDi>
    <basicUdiDi>B-00859389005201</basicUdiDi>
    <tradeName>ProxiCor for Pericardial Closure</tradeName>
    <deviceName>ProxiCor for Pericardial Closure, Single Pack, 7 cm X 15 cm, OUS</deviceName>
    <manufacturerName>Aziyo Biologics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003634</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07020101</emdnCode>
    <emdnDescription>PERICARDIUM VASCULAR PATCHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCV-118-402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:25.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859389005195</udiDi>
    <basicUdiDi>B-00859389005195</basicUdiDi>
    <tradeName>ProxiCor for Pericardial Closure</tradeName>
    <deviceName>ProxiCor for Pericardial Closure, Single Pack, 7 cm X 10 cm, OUS</deviceName>
    <manufacturerName>Aziyo Biologics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003634</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07020101</emdnCode>
    <emdnDescription>PERICARDIUM VASCULAR PATCHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCV-118-401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:24.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859389005096</udiDi>
    <basicUdiDi>B-00859389005096</basicUdiDi>
    <tradeName>VasCure for Carotid Repair</tradeName>
    <deviceName>VasCure for Carotid Repair, Single Pack, 1 cm X 10 cm, OUS</deviceName>
    <manufacturerName>Aziyo Biologics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003634</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07020102</emdnCode>
    <emdnDescription>SIS (SMALL INTESTINAL SUBMUCOSA) VASCULAR PATCHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCV-073-609</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:16.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859389005089</udiDi>
    <basicUdiDi>B-00859389005089</basicUdiDi>
    <tradeName>VasCure for Carotid Repair</tradeName>
    <deviceName>VasCure for Carotid Repair, Single Pack, 2 cm x 10 cm, OUS</deviceName>
    <manufacturerName>Aziyo Biologics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003634</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P07020102</emdnCode>
    <emdnDescription>SIS (SMALL INTESTINAL SUBMUCOSA) VASCULAR PATCHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCV-072-606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:43:12.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858254006022</udiDi>
    <basicUdiDi>B-00858254006022</basicUdiDi>
    <tradeName>Venclose digiRF Generator</tradeName>
    <deviceName>Venclose digiRF Generator</deviceName>
    <manufacturerName>Venclose, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001372</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VC-RFG-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:35:09.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>00858254006015</udiDi>
    <basicUdiDi>B-00858254006015</basicUdiDi>
    <tradeName>Venclose EVSRF Catheter</tradeName>
    <deviceName>Venclose RF Ablation Catheter</deviceName>
    <manufacturerName>Venclose, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001372</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01901902</emdnCode>
    <emdnDescription>RADIOFREQUENCY VENOUS ABLATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VC-10A2.5-6F-100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:35:08.301Z</lastUpdated>
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</eudamedExport>