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    <basicUdiDi>B-08717853298196</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640F-40B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.748Z</lastUpdated>
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    <udiDi>08717853298202</udiDi>
    <basicUdiDi>B-08717853298202</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>645F-20B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.726Z</lastUpdated>
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    <udiDi>08717853298219</udiDi>
    <basicUdiDi>B-08717853298219</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>645F-40B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.703Z</lastUpdated>
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    <udiDi>08717853298226</udiDi>
    <basicUdiDi>B-08717853298226</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650F-20B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.683Z</lastUpdated>
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    <udiDi>08717853298233</udiDi>
    <basicUdiDi>B-08717853298233</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650F-40B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.662Z</lastUpdated>
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    <udiDi>08717853298240</udiDi>
    <basicUdiDi>B-08717853298240</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ø 5.5 x 20 mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.635Z</lastUpdated>
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  <row>
    <udiDi>08717853298257</udiDi>
    <basicUdiDi>B-08717853298257</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>655F-40B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298264</udiDi>
    <basicUdiDi>B-08717853298264</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660F-20B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298271</udiDi>
    <basicUdiDi>B-08717853298271</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660F-40B-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298288</udiDi>
    <basicUdiDi>B-08717853298288</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640F-20A-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.552Z</lastUpdated>
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  <row>
    <udiDi>08717853298295</udiDi>
    <basicUdiDi>B-08717853298295</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>640F-40A-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298301</udiDi>
    <basicUdiDi>B-08717853298301</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650F-20A-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298318</udiDi>
    <basicUdiDi>B-08717853298318</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>650F-40A-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298325</udiDi>
    <basicUdiDi>B-08717853298325</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660F-20A-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.468Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298332</udiDi>
    <basicUdiDi>B-08717853298332</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>660F-40A-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717853298349</udiDi>
    <basicUdiDi>B-08717853298349</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620E-15X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.424Z</lastUpdated>
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  <row>
    <udiDi>08717853298356</udiDi>
    <basicUdiDi>B-08717853298356</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620E-20X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.405Z</lastUpdated>
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    <udiDi>08717853298363</udiDi>
    <basicUdiDi>B-08717853298363</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>620E-40X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.382Z</lastUpdated>
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    <udiDi>08717853298370</udiDi>
    <basicUdiDi>B-08717853298370</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625E-15X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.362Z</lastUpdated>
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    <udiDi>08717853298387</udiDi>
    <basicUdiDi>B-08717853298387</basicUdiDi>
    <tradeName>Scoreflex PTA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrbusNeich Medical, B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000010907</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>625E-20X-31</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:34:51.338Z</lastUpdated>
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