<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06942265514257</udiDi>
    <basicUdiDi>695848140064MH</basicUdiDi>
    <tradeName>Parafleet SC 018</tradeName>
    <deviceName>Minerva Pro / Parafleet SC 018 PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>BrosMed Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007501</manufacturerSrn>
    <authorisedRepresentativeName>Brosmed Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002616</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F18-100040-150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:36:41.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942265500014</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Parafleet SC 014</tradeName>
    <deviceName>Polux Pro / Parafleet SC 014 PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>BrosMed Medical Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007501</manufacturerSrn>
    <authorisedRepresentativeName>Brosmed Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002616</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F14-010015-070</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:36:40.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931896111034</udiDi>
    <basicUdiDi>69494504SC107QW</basicUdiDi>
    <tradeName>Tresfort™</tradeName>
    <deviceName>Tresfort™ 18 PTA Balloon Catheter</deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009046</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107200200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:06:51.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>06943718272014</udiDi>
    <basicUdiDi>69437182VelutFS</basicUdiDi>
    <tradeName>06943718272014</tradeName>
    <deviceName>PTA Balloon Dilatation Catheters</deviceName>
    <manufacturerName>Beijing Demax Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005844</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMC03020-35040</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:40:38.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733776001</udiDi>
    <basicUdiDi>69367337LP0034MP</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS061638</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:20.349Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733748022</udiDi>
    <basicUdiDi>69367337LP0033MM</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS041135-HS45-IC18-K-S</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:09.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733748015</udiDi>
    <basicUdiDi>69367337LP0030MF</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS040525</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:05.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733747971</udiDi>
    <basicUdiDi>69367337LP0035MR</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LS062338-SJ70-IN18-K-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:03.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733741122</udiDi>
    <basicUdiDi>69367337LP0032MK</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS061135-NJ45-IN18</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:47.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733730898</udiDi>
    <basicUdiDi>69367337LP0029MW</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS050721-HS45-IC22-K-S</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:45.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733729762</udiDi>
    <basicUdiDi>69367337LP0038MX</basicUdiDi>
    <tradeName>Brilliant™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSC061125-SS45-IN20-K-S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:38.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733729717</udiDi>
    <basicUdiDi>69367337LP0040MJ</basicUdiDi>
    <tradeName>Brilliant™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSC051125-HS45-IC20-K-S</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:37.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733729564</udiDi>
    <basicUdiDi>69367337LP0031MH</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS071138-SJ45-IN18</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:37.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733710852</udiDi>
    <basicUdiDi>69367337LP0037MV</basicUdiDi>
    <tradeName>Brilliant™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RSC040721</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:37.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733710777</udiDi>
    <basicUdiDi>69367337LP0026MQ</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS070718</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:33.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733704967</udiDi>
    <basicUdiDi>69367337LP0027MS</basicUdiDi>
    <tradeName>Shoocin™</tradeName>
    <deviceName>Introducer Kit</deviceName>
    <manufacturerName>Lepu Medical Technology (Beijing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001408</manufacturerSrn>
    <authorisedRepresentativeName>Lepu Medical (Europe) Cooperatief U.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000551</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040280</emdnCode>
    <emdnDescription>PERIPHERAL ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS050725-SS45-IN20</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:58:24.802Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955936968</udiDi>
    <basicUdiDi>69349559582ZV</basicUdiDi>
    <tradeName>JADE PLUS</tradeName>
    <deviceName>JADE PLUS Balloon Dilatation Catheter</deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5935-040-12</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:57:31.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931473304491</udiDi>
    <basicUdiDi>69314733MP01QT</basicUdiDi>
    <tradeName>06931473304491</tradeName>
    <deviceName>Peripheral Microcatheter</deviceName>
    <manufacturerName>Shanghai Shenqi Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013667</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104020101</emdnCode>
    <emdnDescription>PANORAMIC AND SELECTIVE PERIPHERAL DIAGNOSTIC ANGIOGRAPHY CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MP2110520</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:49:45.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931473303500</udiDi>
    <basicUdiDi>69314733CP01NM</basicUdiDi>
    <tradeName>SQ-WindRider</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Shenqi Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013667</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020301</emdnCode>
    <emdnDescription>EMBOLISATION COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP18010306</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:49:44.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>05391530910149</udiDi>
    <basicUdiDi>539153091pNOVUSFAMILYYK</basicUdiDi>
    <tradeName>pNOVUS 21 Microcatheter</tradeName>
    <deviceName>pNOVUS 21 Microcatheter</deviceName>
    <manufacturerName>phenox Ltd</manufacturerName>
    <manufacturerSrn>IE-MF-000011333</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104020202</emdnCode>
    <emdnDescription>PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNOV-21-160</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:56:18.079Z</lastUpdated>
  </row>
</eudamedExport>