<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06934955912160</udiDi>
    <basicUdiDi>B-06934955912160</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593015035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912177</udiDi>
    <basicUdiDi>B-06934955912177</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593018035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912184</udiDi>
    <basicUdiDi>B-06934955912184</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593024035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912191</udiDi>
    <basicUdiDi>B-06934955912191</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593501535</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912207</udiDi>
    <basicUdiDi>B-06934955912207</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593502035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912214</udiDi>
    <basicUdiDi>B-06934955912214</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593504035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912221</udiDi>
    <basicUdiDi>B-06934955912221</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593506035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912238</udiDi>
    <basicUdiDi>B-06934955912238</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593508035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.351Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912245</udiDi>
    <basicUdiDi>B-06934955912245</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593510035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912252</udiDi>
    <basicUdiDi>B-06934955912252</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593512035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912269</udiDi>
    <basicUdiDi>B-06934955912269</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593515035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912276</udiDi>
    <basicUdiDi>B-06934955912276</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593518035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912283</udiDi>
    <basicUdiDi>B-06934955912283</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>593524035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912290</udiDi>
    <basicUdiDi>B-06934955912290</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594001535</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.222Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912306</udiDi>
    <basicUdiDi>B-06934955912306</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594002035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912313</udiDi>
    <basicUdiDi>B-06934955912313</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594004035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912320</udiDi>
    <basicUdiDi>B-06934955912320</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594006035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912337</udiDi>
    <basicUdiDi>B-06934955912337</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594008035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912344</udiDi>
    <basicUdiDi>B-06934955912344</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594010035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955912351</udiDi>
    <basicUdiDi>B-06934955912351</basicUdiDi>
    <tradeName>JADE PTA (JADE 18 OTW)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical (Shenzhen) Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000011345</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>594012035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:38:53.074Z</lastUpdated>
  </row>
</eudamedExport>