<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936841227839</udiDi>
    <basicUdiDi>697116281BID10AJ</basicUdiDi>
    <tradeName>06936841227839</tradeName>
    <deviceName>Balloon Inflation Device</deviceName>
    <manufacturerName>Tianck Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007451</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:37.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014455197</udiDi>
    <basicUdiDi>69560144CCBDCKH</basicUdiDi>
    <tradeName>SafeCut</tradeName>
    <deviceName>Coronary Cutting Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635519</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:56.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>06956014457474</udiDi>
    <basicUdiDi>69560144GECZF</basicUdiDi>
    <tradeName>Slender</tradeName>
    <deviceName>Guiding Extention Catheter</deviceName>
    <manufacturerName>Shunmei Medical Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010202</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY GUIDE CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>635747</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:54.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949450407189</udiDi>
    <basicUdiDi>69494504RYC1801YK</basicUdiDi>
    <tradeName>SealingPro</tradeName>
    <deviceName>SealingPro™ Y Connector</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>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18821100</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:07.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949450407158</udiDi>
    <basicUdiDi>69494504RYC1803YP</basicUdiDi>
    <tradeName>SealingPro</tradeName>
    <deviceName>SealingPro™ Y Connector</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>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18471100</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:03.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>06949450407134</udiDi>
    <basicUdiDi>69494504RYC1802YM</basicUdiDi>
    <tradeName>SealingPro</tradeName>
    <deviceName>SealingPro™ Y Connector</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>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18992200</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:14:02.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931896161992</udiDi>
    <basicUdiDi>69494504IFD19R6</basicUdiDi>
    <tradeName>Enlarger™Pro</tradeName>
    <deviceName>Enlarger™ Inflation Device</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040180</emdnCode>
    <emdnDescription>CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2052050S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:06:52.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936733794104</udiDi>
    <basicUdiDi>69367337LP0024ML</basicUdiDi>
    <tradeName>Angiopower™</tradeName>
    <deviceName>Inflation Device</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>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP-P-30</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:59:21.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927741087043</udiDi>
    <basicUdiDi>69277410ZBT0004TH</basicUdiDi>
    <tradeName>Sterile HP PTA Balloon Catheter</tradeName>
    <deviceName>Sterile HP PTA Balloon Catheter</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G100020002014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:23.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927741079642</udiDi>
    <basicUdiDi>69277410ZBT0003TF</basicUdiDi>
    <tradeName>Sterile PTA Balloon Catheter</tradeName>
    <deviceName>Sterile PTA Balloon Catheter</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H100015002014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:22.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>06927741079055</udiDi>
    <basicUdiDi>69277410ZBT0001TB</basicUdiDi>
    <tradeName>Sterile PTCA Balloon Catheter</tradeName>
    <deviceName>Sterile PTCA Balloon Catheter</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PG37515</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:45:21.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>05065021834091</udiDi>
    <basicUdiDi>5065021834SYNPP009ZH</basicUdiDi>
    <tradeName>SYNDEOpack Interventional Procedure Pack</tradeName>
    <deviceName>Angiography Pack-02</deviceName>
    <manufacturerName>SYNDEO Medical</manufacturerName>
    <manufacturerSrn>BE-PR-000044136</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010199</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SYN-ANG02-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:17:17.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897111860274</udiDi>
    <basicUdiDi>489711186CSYR</basicUdiDi>
    <tradeName>Dr.ANA® control syringes</tradeName>
    <deviceName>Control Syringes</deviceName>
    <manufacturerName>ANNI AND ANNA LIMITED</manufacturerName>
    <manufacturerSrn>HK-MF-000036709</manufacturerSrn>
    <authorisedRepresentativeName>Ellecom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA-CS-10RRR-TB</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:14:45.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897111860090</udiDi>
    <basicUdiDi>489711186HVZE</basicUdiDi>
    <tradeName>Dr.ANA® haemostatic valves</tradeName>
    <deviceName>Haemostatic valves</deviceName>
    <manufacturerName>ANNI AND ANNA LIMITED</manufacturerName>
    <manufacturerSrn>HK-MF-000036709</manufacturerSrn>
    <authorisedRepresentativeName>Ellecom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010280</emdnCode>
    <emdnDescription>INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA-HV-7CPLCR-TB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:14:45.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>04897111860014</udiDi>
    <basicUdiDi>489711186IDYD</basicUdiDi>
    <tradeName>Dr.ANA® disposable balloon inflation devices</tradeName>
    <deviceName>Disposable balloon inflation devices</deviceName>
    <manufacturerName>ANNI AND ANNA LIMITED</manufacturerName>
    <manufacturerSrn>HK-MF-000036709</manufacturerSrn>
    <authorisedRepresentativeName>Ellecom GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000012869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020180</emdnCode>
    <emdnDescription>PTCA BALLOON DILATATION CATHETERS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA-ID-A2530HP14-TB</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:14:44.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327120180</udiDi>
    <basicUdiDi>4547327ADC016GQ</basicUdiDi>
    <tradeName>SASUKE</tradeName>
    <deviceName>SASUKE Double Lumen Catheter (RX/OTW)</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010203</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA145-33N</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:53:35.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>04547327137829</udiDi>
    <basicUdiDi>4547327AMC021KL</basicUdiDi>
    <tradeName>Corsair Pro XS</tradeName>
    <deviceName>Corsair Pro XS Microcatheter</deviceName>
    <manufacturerName>ASAHI INTECC CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000010199</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010203</emdnCode>
    <emdnDescription>PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CSR135-21S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:53:33.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>04251790255194</udiDi>
    <basicUdiDi>42517902VBCVE</basicUdiDi>
    <tradeName>Calbreak</tradeName>
    <deviceName>Coronary Cutting Balloon Dilatation Catheter</deviceName>
    <manufacturerName>SWL Medizin GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008000</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>835519</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:07:54.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250347605543</udiDi>
    <basicUdiDi>42503476LEITUNGSSYSTMEUP</basicUdiDi>
    <tradeName>Spiralleitung 200 cm mit Y-Verbinder</tradeName>
    <deviceName>Leitungssysteme für Angiographie, Kardiologie, Radiologie</deviceName>
    <manufacturerName>RoweMed AG - Medical 4 Life</manufacturerName>
    <manufacturerSrn>DE-MF-000005350</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C01040199</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-7032/65</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:05:51.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699195507757</udiDi>
    <basicUdiDi>086991955Alvision5D</basicUdiDi>
    <tradeName>Alvision</tradeName>
    <deviceName>Alvision Interventional Cardiology Diagnostic Catheter</deviceName>
    <manufacturerName>Alvimedica Tibbi Urunler San. ve Dis Tic. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000029915</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0104010101</emdnCode>
    <emdnDescription>CARDIAC ANGIOGRAPHY DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>501110019893</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:22:22.566Z</lastUpdated>
  </row>
</eudamedExport>