<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>14543660022768</udiDi>
    <basicUdiDi>4543660GMW132A100000000TQ</basicUdiDi>
    <tradeName>GOODTEC Y-CONNECTOR SET</tradeName>
    <deviceName>GOODTEC Y-CONNECTOR SET</deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C900101</emdnCode>
    <emdnDescription>HAEMOSTASIS VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YOK0A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:46:53.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025595</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-05040040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T20:45:44.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025601</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-05050040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025618</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-05060040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025625</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-05070040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025632</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-05080040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025649</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-09040040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025656</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-09050040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025663</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-09060040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025670</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-09070040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025687</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA18-09080040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025694</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-05040040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025700</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-05050040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.110Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025717</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-05060040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025724</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-05070040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025731</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-05080040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025748</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-09040040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025755</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-09050040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025762</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-09060040</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:14.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>04543660025779</udiDi>
    <basicUdiDi>4543660GMW172A100000000YC</basicUdiDi>
    <tradeName>Aperta NSE PTA Balloon Dilatation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIPRO VASCULAR CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000001989</manufacturerSrn>
    <authorisedRepresentativeName>Nipro Vascular Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000771</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW18-09070040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:01:13.998Z</lastUpdated>
  </row>
</eudamedExport>