<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033860034504</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS BALLOON CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKB1315</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034528</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS BALLOON CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AKB1320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860035006</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOSET CLASSIC ACCESS SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11KSL02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:52.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860035075</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOSET FAST ACCESS SYSTEM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11KSD02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:51.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860035549</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOSET BONE FILLER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11KSFILLER6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:51.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860036058</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>SANZA BALLOON CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAL-010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:50.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860036072</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>SANZA BALLOON CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAL-010-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:50.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860036096</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>SANZA BALLOON CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAL-015-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:50.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860036119</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>SANZA BALLOON CATHETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAL-020-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:50.260Z</lastUpdated>
  </row>
</eudamedExport>