<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936733775035</udiDi>
    <basicUdiDi>69367337LP0019MT</basicUdiDi>
    <tradeName>Angioway™</tradeName>
    <deviceName>Contrast Medium Injection Manifold 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>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-018</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:13.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733775004</udiDi>
    <basicUdiDi>69367337LP0018MR</basicUdiDi>
    <tradeName>Angioway™</tradeName>
    <deviceName>Contrast Medium Injection Manifold 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>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MK-006</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:11.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817612020957</udiDi>
    <basicUdiDi>0817612026226M</basicUdiDi>
    <tradeName>Dale Transducer Holder</tradeName>
    <deviceName>Transducer Holder</deviceName>
    <manufacturerName>Dale Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019061</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:59:30.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817612020841</udiDi>
    <basicUdiDi>0817612026206H</basicUdiDi>
    <tradeName>Dale Transducer Holder</tradeName>
    <deviceName>Transducer Holder</deviceName>
    <manufacturerName>Dale Medical Products, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019061</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:59:25.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YConnectorPackBN</udiDi>
    <basicUdiDi>B-YConnectorPackBN</basicUdiDi>
    <tradeName>Y Connector Pack</tradeName>
    <deviceName>Y Connector Pack</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YCK111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:02:29.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NeuronET</udiDi>
    <basicUdiDi>B-NeuronET</basicUdiDi>
    <tradeName>Neuron Delivery Catheter (115cm/12cm)</tradeName>
    <deviceName>Neuron Intracranial Access System</deviceName>
    <manufacturerName>Penumbra, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008514</manufacturerSrn>
    <authorisedRepresentativeName>Penumbra Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004997</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PND6F11512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:08:26.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ManifoldkitAQ</udiDi>
    <basicUdiDi>B-ManifoldkitAQ</basicUdiDi>
    <tradeName>Manifold Kit</tradeName>
    <deviceName>Manifold Kit</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0350,</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:18:40.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DDCBY</udiDi>
    <basicUdiDi>B-DDCBY</basicUdiDi>
    <tradeName>4MAX DDC - Distal Delivery Catheter, 130 cm</tradeName>
    <deviceName>Distal Delivery Catheters</deviceName>
    <manufacturerName>Penumbra, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008514</manufacturerSrn>
    <authorisedRepresentativeName>Penumbra Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004997</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4MAXDDC130</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:17:28.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BenchmarkG6</udiDi>
    <basicUdiDi>B-BenchmarkG6</basicUdiDi>
    <tradeName>6F Benchmark  95cm Straight</tradeName>
    <deviceName>Benchmark Intracranial Access System</deviceName>
    <manufacturerName>Penumbra, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008514</manufacturerSrn>
    <authorisedRepresentativeName>Penumbra Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000004997</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BMK6F95</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:30:27.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401470</udiDi>
    <basicUdiDi>B-18904314401470</basicUdiDi>
    <tradeName>Radial Artery Compression Device</tradeName>
    <deviceName>AD-BAND Radial Artery Compression Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADB29</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:34:27.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401463</udiDi>
    <basicUdiDi>B-18904314401463</basicUdiDi>
    <tradeName>Radial Artery Compression Device</tradeName>
    <deviceName>AD-BAND Radial Artery Compression Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADB27</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:34:26.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401456</udiDi>
    <basicUdiDi>B-18904314401456</basicUdiDi>
    <tradeName>Radial Artery Compression Device</tradeName>
    <deviceName>AD-BAND Radial Artery Compression Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADB24</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:34:22.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401449</udiDi>
    <basicUdiDi>B-18904314401449</basicUdiDi>
    <tradeName>Radial Artery Compression Device</tradeName>
    <deviceName>AD-BAND Radial Artery Compression Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADB21</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:34:21.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401272</udiDi>
    <basicUdiDi>B-18904314401272</basicUdiDi>
    <tradeName>Inflation Device</tradeName>
    <deviceName>Indeflate Inflation Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IID 20-30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:51.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401265</udiDi>
    <basicUdiDi>B-18904314401265</basicUdiDi>
    <tradeName>Inflation Device</tradeName>
    <deviceName>Divine Inflation Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DID 25-30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:51.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904314401258</udiDi>
    <basicUdiDi>B-18904314401258</basicUdiDi>
    <tradeName>Inflation Device</tradeName>
    <deviceName>Easy Inflation Device</deviceName>
    <manufacturerName>Advanced LifeSciences Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000016421</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EID 20-30</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:33:49.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941785262730</udiDi>
    <basicUdiDi>69367337LP0045MU</basicUdiDi>
    <tradeName>06941785262730</tradeName>
    <deviceName>Sterile IVL Sleeve</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT-A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:12:10.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251934200714</udiDi>
    <basicUdiDi>42519342TR003EW</basicUdiDi>
    <tradeName>04251934200714</tradeName>
    <deviceName>Bracket</deviceName>
    <manufacturerName>Shenzhen Keborui Electronics Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000007718</manufacturerSrn>
    <authorisedRepresentativeName>Tri Rad Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006744</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:14:09.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950900999970</udiDi>
    <basicUdiDi>69509009CEMKSA</basicUdiDi>
    <tradeName>06950900999970</tradeName>
    <deviceName>Manifold Kit</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0352M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:26:51.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950900982156</udiDi>
    <basicUdiDi>69509009CEMKSA</basicUdiDi>
    <tradeName>06950900982156</tradeName>
    <deviceName>Manifold Kit</deviceName>
    <manufacturerName>Shanghai INT Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009966</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010480</emdnCode>
    <emdnDescription>ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM0352F-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:21:18.960Z</lastUpdated>
  </row>
</eudamedExport>