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<eudamedExport entity="devices">
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    <basicUdiDi>426012378ThrombectomyF6</basicUdiDi>
    <tradeName>pRESET STANDARD Thrombectomy Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>phenox GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006524</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C010402020702</emdnCode>
    <emdnDescription>MECHANICAL PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PRES-5-40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-03T19:55:47.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955941344</udiDi>
    <basicUdiDi>B-06934955941344</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName>Scoreflex PTA Balloon Dilatation Catheter</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>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL635-154C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-03T11:11:38.218Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955906978</udiDi>
    <basicUdiDi>B-06934955906978</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605002015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.334Z</lastUpdated>
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  <row>
    <udiDi>06934955906985</udiDi>
    <basicUdiDi>B-06934955906985</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605004015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955906992</udiDi>
    <basicUdiDi>B-06934955906992</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605006015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907005</udiDi>
    <basicUdiDi>B-06934955907005</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605008015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907012</udiDi>
    <basicUdiDi>B-06934955907012</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605010015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907029</udiDi>
    <basicUdiDi>B-06934955907029</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605015015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.203Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907036</udiDi>
    <basicUdiDi>B-06934955907036</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605018015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907043</udiDi>
    <basicUdiDi>B-06934955907043</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>605024015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907050</udiDi>
    <basicUdiDi>B-06934955907050</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606002015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907067</udiDi>
    <basicUdiDi>B-06934955907067</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606004015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907074</udiDi>
    <basicUdiDi>B-06934955907074</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606006015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907081</udiDi>
    <basicUdiDi>B-06934955907081</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606008015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934955907098</udiDi>
    <basicUdiDi>B-06934955907098</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606010015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.032Z</lastUpdated>
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  <row>
    <udiDi>06934955907104</udiDi>
    <basicUdiDi>B-06934955907104</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606015015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:57.018Z</lastUpdated>
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  <row>
    <udiDi>06934955907111</udiDi>
    <basicUdiDi>B-06934955907111</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606018015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:56.998Z</lastUpdated>
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  <row>
    <udiDi>06934955907128</udiDi>
    <basicUdiDi>B-06934955907128</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>606024015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:56.980Z</lastUpdated>
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  <row>
    <udiDi>06934955907135</udiDi>
    <basicUdiDi>B-06934955907135</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>607002015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:56.947Z</lastUpdated>
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  <row>
    <udiDi>06934955907142</udiDi>
    <basicUdiDi>B-06934955907142</basicUdiDi>
    <tradeName>JADE PTA (JADE 35 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>607004015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-03T00:58:56.919Z</lastUpdated>
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