<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08857127156149</udiDi>
    <basicUdiDi>B-08857127156149</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 4 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP04-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156156</udiDi>
    <basicUdiDi>B-08857127156156</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 6 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP06-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156163</udiDi>
    <basicUdiDi>B-08857127156163</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 8 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP08-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156170</udiDi>
    <basicUdiDi>B-08857127156170</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 10 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP10-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156187</udiDi>
    <basicUdiDi>B-08857127156187</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 12 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP12-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156194</udiDi>
    <basicUdiDi>B-08857127156194</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 14 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP14-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156200</udiDi>
    <basicUdiDi>B-08857127156200</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 16 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP16-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156217</udiDi>
    <basicUdiDi>B-08857127156217</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 18 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP18-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156224</udiDi>
    <basicUdiDi>B-08857127156224</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 20 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP20-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156231</udiDi>
    <basicUdiDi>B-08857127156231</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug II – 22 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP22-II</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156248</udiDi>
    <basicUdiDi>B-08857127156248</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug IV – 4 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP04-IV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156255</udiDi>
    <basicUdiDi>B-08857127156255</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug IV – 6 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP06-IV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156262</udiDi>
    <basicUdiDi>B-08857127156262</basicUdiDi>
    <tradeName>ChekFLO Vascular Plug IV – 8 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVP08-IV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:20:07.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156132</udiDi>
    <basicUdiDi>B-08857127156132</basicUdiDi>
    <tradeName>OMEGA LAA Occluder Delivery System 14F</tradeName>
    <deviceName>OMEGA LAA Occluder Delivery System 14F</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA14F</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:21:06.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156101</udiDi>
    <basicUdiDi>B-08857127156101</basicUdiDi>
    <tradeName>OMEGA LAA Occluder 30mm</tradeName>
    <deviceName>OMEGA LAA Occluder 30mm</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070404</emdnCode>
    <emdnDescription>LEFT ATRIAL APPENDAGE OCCLUDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA30</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:21:00.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156095</udiDi>
    <basicUdiDi>B-08857127156095</basicUdiDi>
    <tradeName>OMEGA LAA Occluder 28mm</tradeName>
    <deviceName>OMEGA LAA Occluder 28mm</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070404</emdnCode>
    <emdnDescription>LEFT ATRIAL APPENDAGE OCCLUDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA28</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:20:59.710Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156088</udiDi>
    <basicUdiDi>B-08857127156088</basicUdiDi>
    <tradeName>OMEGA LAA Occluder 26mm</tradeName>
    <deviceName>OMEGA LAA Occluder 26mm</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070404</emdnCode>
    <emdnDescription>LEFT ATRIAL APPENDAGE OCCLUDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA26</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:20:58.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156071</udiDi>
    <basicUdiDi>B-08857127156071</basicUdiDi>
    <tradeName>OMEGA LAA Occluder 24mm</tradeName>
    <deviceName>OMEGA LAA Occluder 24mm</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070404</emdnCode>
    <emdnDescription>LEFT ATRIAL APPENDAGE OCCLUDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA24</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:20:57.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156064</udiDi>
    <basicUdiDi>B-08857127156064</basicUdiDi>
    <tradeName>OMEGA LAA Occluder 22mm</tradeName>
    <deviceName>OMEGA LAA Occluder 22mm</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070404</emdnCode>
    <emdnDescription>LEFT ATRIAL APPENDAGE OCCLUDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA22</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:20:51.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>08857127156057</udiDi>
    <basicUdiDi>B-08857127156057</basicUdiDi>
    <tradeName>OMEGA LAA Occluder 20mm</tradeName>
    <deviceName>OMEGA LAA Occluder 20mm</deviceName>
    <manufacturerName>Eclipse Medical Co. Ltd</manufacturerName>
    <manufacturerSrn>TH-MF-000021672</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070404</emdnCode>
    <emdnDescription>LEFT ATRIAL APPENDAGE OCCLUDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLAA20</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T04:20:50.102Z</lastUpdated>
  </row>
</eudamedExport>