<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08057500100329</udiDi>
    <basicUdiDi>805750010FLOWER9S</basicUdiDi>
    <tradeName>FLOWer</tradeName>
    <deviceName>FLOWer Transcatheter Antiembolic Filter</deviceName>
    <manufacturerName>AORTICLAB s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000026729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-TAF-032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:23:02.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>08057500100282</udiDi>
    <basicUdiDi>805750010FLOWER9S</basicUdiDi>
    <tradeName>FLOWer</tradeName>
    <deviceName>FLOWer Transcatheter Antiembolic Filter</deviceName>
    <manufacturerName>AORTICLAB s.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000026729</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PF-TAF-028</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:14:25.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429021226</udiDi>
    <basicUdiDi>69454290SC001N5</basicUdiDi>
    <tradeName>Sequential Compression System</tradeName>
    <deviceName>Sequential Compression System</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCD600</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:11:47.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680400433688</udiDi>
    <basicUdiDi>B-08680400433688</basicUdiDi>
    <tradeName>REYA Reya Trombektomi Sistem V</tradeName>
    <deviceName>Reya Trombektomi Sistem V</deviceName>
    <manufacturerName>FG GRUP SAĞLIK İNŞAAT HARİTA MİMARLIK MÜHENDİSLİK ELEKTRONİK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027182</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:11:31.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>08680400433572</udiDi>
    <basicUdiDi>B-08680400433572</basicUdiDi>
    <tradeName>REYA Reya Trombektomi Sistem VI</tradeName>
    <deviceName>Reya Trombektomi Sistem VI</deviceName>
    <manufacturerName>FG GRUP SAĞLIK İNŞAAT HARİTA MİMARLIK MÜHENDİSLİK ELEKTRONİK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027182</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ATA0012</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T14:11:23.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437019519001</udiDi>
    <basicUdiDi>8437019519ANAB6</basicUdiDi>
    <tradeName>ANA5 Advanced Neurovascular Access</tradeName>
    <deviceName>ANA5 Advanced Neurovascular Access</deviceName>
    <manufacturerName>ANACONDA BIOMED, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000009187</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-00003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:36.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015107051</udiDi>
    <basicUdiDi>7290015107ANPP1TU</basicUdiDi>
    <tradeName>Comaneci 17 Embolization assist device</tradeName>
    <deviceName>Comaneci, Comaneci Petit, Comaneci 17</deviceName>
    <manufacturerName>Rapid Medical Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000012181</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011191</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANPP3199</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:53:52.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015107044</udiDi>
    <basicUdiDi>7290015107ANPP1TU</basicUdiDi>
    <tradeName>Comaneci Petit Embolization assist device</tradeName>
    <deviceName>Comaneci, Comaneci Petit, Comaneci 17</deviceName>
    <manufacturerName>Rapid Medical Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000012181</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011191</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANPP3188</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:53:50.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290015107013</udiDi>
    <basicUdiDi>7290015107ANPP1TU</basicUdiDi>
    <tradeName>Comaneci Embolization assist device</tradeName>
    <deviceName>Comaneci, Comaneci Petit, Comaneci 17</deviceName>
    <manufacturerName>Rapid Medical Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000012181</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011191</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ANPP3177, ANPP3188, ANPP3199</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:53:43.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973746570028</udiDi>
    <basicUdiDi>B-06973746570028</basicUdiDi>
    <tradeName>LAVA</tradeName>
    <deviceName>Lava Liquid Embolic System</deviceName>
    <manufacturerName>NeuroSafe Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034098</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAVA-34</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:42:39.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973746570011</udiDi>
    <basicUdiDi>B-06973746570011</basicUdiDi>
    <tradeName>LAVA</tradeName>
    <deviceName>Lava Liquid Embolic System</deviceName>
    <manufacturerName>NeuroSafe Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034098</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAVA-18</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:42:38.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973746570004</udiDi>
    <basicUdiDi>B-06973746570004</basicUdiDi>
    <tradeName>06973746570004</tradeName>
    <deviceName>Lava Liquid Embolic System</deviceName>
    <manufacturerName>NeuroSafe Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000034098</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B-06973746570011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T08:42:37.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209572</udiDi>
    <basicUdiDi>B-06970757209572</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:39.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209565</udiDi>
    <basicUdiDi>B-06970757209565</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:37.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209558</udiDi>
    <basicUdiDi>B-06970757209558</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:36.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209541</udiDi>
    <basicUdiDi>B-06970757209541</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:30.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209534</udiDi>
    <basicUdiDi>B-06970757209534</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:29.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209527</udiDi>
    <basicUdiDi>B-06970757209527</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:28.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209510</udiDi>
    <basicUdiDi>B-06970757209510</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:27.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970757209503</udiDi>
    <basicUdiDi>B-06970757209503</basicUdiDi>
    <tradeName>SkyGuard</tradeName>
    <deviceName>Balloon Guide Catheter</deviceName>
    <manufacturerName>Skynor Medical（Shanghai）Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000028227</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C01050299</emdnCode>
    <emdnDescription>INTRAVASCULAR EMBOLIC PROTECTION CATHETERS AND SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:22:21.126Z</lastUpdated>
  </row>
</eudamedExport>