<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06958481487800</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020100-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:11.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487794</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020080-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:10.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487787</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020060-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:04.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487770</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020040-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:02.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487763</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020030-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:01.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487756</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020025-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:12:00.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487749</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020020-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:54.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487732</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-020015-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:53.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487725</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-015200-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:51.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487718</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-015150-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:50.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487701</udiDi>
    <basicUdiDi>695848140063MF</basicUdiDi>
    <tradeName>Polux Pro</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>P14-015120-090</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:43.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487169</udiDi>
    <basicUdiDi>B-06958481487169</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431230</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:42.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487152</udiDi>
    <basicUdiDi>B-06958481487152</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431225</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:41.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487145</udiDi>
    <basicUdiDi>B-06958481487145</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431220</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:40.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487138</udiDi>
    <basicUdiDi>B-06958481487138</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431215</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:33.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487121</udiDi>
    <basicUdiDi>B-06958481487121</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431212</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:32.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487114</udiDi>
    <basicUdiDi>B-06958481487114</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431210</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:31.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487107</udiDi>
    <basicUdiDi>B-06958481487107</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431208</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:30.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487091</udiDi>
    <basicUdiDi>B-06958481487091</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431205</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:23.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958481487084</udiDi>
    <basicUdiDi>B-06958481487084</basicUdiDi>
    <tradeName>Aperi SC</tradeName>
    <deviceName>Aperi SC Balloon Dilatation Catheters</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 III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>431030</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:11:21.994Z</lastUpdated>
  </row>
</eudamedExport>