<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08720214000093</udiDi>
    <basicUdiDi>B-08720214000093</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName>SteerEase™ Introducer</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-SFA6F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:06:21.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720214000086</udiDi>
    <basicUdiDi>B-08720214000086</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName>SteerEase™ Introducer</deviceName>
    <manufacturerName>LifeTech Scientific (Europe) B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000005742</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LE-SFA5F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:06:21.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400468</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName>Occlutech Pistol Pusher</deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP090</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:14:07.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400475</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP090L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:19.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400482</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:19.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400499</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP125L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:19.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400505</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP165</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:19.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400512</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP165L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:19.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400529</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP185</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:19.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400536</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP185L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:18.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400543</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:18.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683463400550</udiDi>
    <basicUdiDi>86834634OPP82</basicUdiDi>
    <tradeName>Occlutech Pistol Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Occlutech Tıbbi Ürünler San. ve Tic. Ltd. Şti</manufacturerName>
    <manufacturerSrn>TR-MF-000014931</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>55PP210L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:04:18.828Z</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>06938370125280</udiDi>
    <basicUdiDi>B-06938370125280</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA14F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:17.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938370125273</udiDi>
    <basicUdiDi>B-06938370125273</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA12F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:16.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938370125266</udiDi>
    <basicUdiDi>B-06938370125266</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA10F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:15.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938370125259</udiDi>
    <basicUdiDi>B-06938370125259</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA9F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:14.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938370125242</udiDi>
    <basicUdiDi>B-06938370125242</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA8F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:11.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938370125235</udiDi>
    <basicUdiDi>B-06938370125235</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA7F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:10.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938370125228</udiDi>
    <basicUdiDi>B-06938370125228</basicUdiDi>
    <tradeName>SteerEase</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lifetech Scientific (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001561</manufacturerSrn>
    <authorisedRepresentativeName>LifeTech Scientific (Europe) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000804</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>P0780</emdnCode>
    <emdnDescription>VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFA6F-f</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:36:09.232Z</lastUpdated>
  </row>
</eudamedExport>