<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06971971811244</udiDi>
    <basicUdiDi>B-06971971811244</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135070003035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:24.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811220</udiDi>
    <basicUdiDi>B-06971971811220</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070020035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:22.992Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811213</udiDi>
    <basicUdiDi>B-06971971811213</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070018035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:22.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811237</udiDi>
    <basicUdiDi>B-06971971811237</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135070002035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:20.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811206</udiDi>
    <basicUdiDi>B-06971971811206</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070015035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:17.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811190</udiDi>
    <basicUdiDi>B-06971971811190</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070012035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:02.528Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811176</udiDi>
    <basicUdiDi>B-06971971811183</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070008035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:01.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811169</udiDi>
    <basicUdiDi>B-06971971811169</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070006035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:00.925Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811152</udiDi>
    <basicUdiDi>B-06971971811152</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070004035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:31:00.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811145</udiDi>
    <basicUdiDi>B-06971971811145</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070003035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:56.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811138</udiDi>
    <basicUdiDi>B-06971971811138</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH075070002035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:55.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811121</udiDi>
    <basicUdiDi>B-06971971811121</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040070010035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:54.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811114</udiDi>
    <basicUdiDi>B-06971971811114</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040070008035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:53.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811107</udiDi>
    <basicUdiDi>B-06971971811107</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040070006035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:49.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811091</udiDi>
    <basicUdiDi>B-06971971811091</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040070004035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:49.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811084</udiDi>
    <basicUdiDi>B-06971971811084</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040070003035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:48.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811077</udiDi>
    <basicUdiDi>B-06971971811077</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH040070002035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:47.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811060</udiDi>
    <basicUdiDi>B-06971971811060</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135060020035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:43.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811046</udiDi>
    <basicUdiDi>B-06971971811046</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135060015035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:42.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971971811053</udiDi>
    <basicUdiDi>B-06971971811053</basicUdiDi>
    <tradeName>ZENFLOW</tradeName>
    <deviceName>HP PTA  Balloon Catheter</deviceName>
    <manufacturerName>Zylox-Tonbridge Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010626</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZWH135060018035B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:30:41.716Z</lastUpdated>
  </row>
</eudamedExport>