<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06934955908316</udiDi>
    <basicUdiDi>B-06934955908316</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>583510015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:40.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908323</udiDi>
    <basicUdiDi>B-06934955908323</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>583512015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908330</udiDi>
    <basicUdiDi>B-06934955908330</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>583515015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908347</udiDi>
    <basicUdiDi>B-06934955908347</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>583518015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908354</udiDi>
    <basicUdiDi>B-06934955908354</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>583524015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908361</udiDi>
    <basicUdiDi>B-06934955908361</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584002015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908378</udiDi>
    <basicUdiDi>B-06934955908378</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584004015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908385</udiDi>
    <basicUdiDi>B-06934955908385</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584006015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908392</udiDi>
    <basicUdiDi>B-06934955908392</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584008015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908408</udiDi>
    <basicUdiDi>B-06934955908408</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584010015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908415</udiDi>
    <basicUdiDi>B-06934955908415</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584012015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908422</udiDi>
    <basicUdiDi>B-06934955908422</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584015015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908439</udiDi>
    <basicUdiDi>B-06934955908439</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584018015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908446</udiDi>
    <basicUdiDi>B-06934955908446</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>584024015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908453</udiDi>
    <basicUdiDi>B-06934955908453</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>585002015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908460</udiDi>
    <basicUdiDi>B-06934955908460</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>585004015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908477</udiDi>
    <basicUdiDi>B-06934955908477</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>585006015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.514Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908484</udiDi>
    <basicUdiDi>B-06934955908484</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>585008015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908491</udiDi>
    <basicUdiDi>B-06934955908491</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>585010015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955908507</udiDi>
    <basicUdiDi>B-06934955908507</basicUdiDi>
    <tradeName>JADE PTA (JADE 14 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>585012015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:48:39.404Z</lastUpdated>
  </row>
</eudamedExport>