<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07611819525399</udiDi>
    <basicUdiDi>7611819a00286JW</basicUdiDi>
    <tradeName>07611819525399</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</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>03.804.701S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:51:31.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>07611819525405</udiDi>
    <basicUdiDi>7611819a00286JW</basicUdiDi>
    <tradeName>07611819525405</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Synthes GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000013345</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</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>03.804.702S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:51:31.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860024253</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE 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>RES1112002VB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:53:28.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860025939</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT  KIRSCHNER GUIDE</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>KK11-FGT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:53:26.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860027940</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT 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>KK08-001L-AMS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:53:13.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860027971</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>KYPHOKIT 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>KK11-001V-AMS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:53:13.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860033750</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY  WORKING CANNULA AND TROCAR TIP</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>AK11TR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:57.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860033774</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY  WORKING CANNULA AND DIAMOND TIP</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>AK11DI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:57.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860033859</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>AKB10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:57.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860033873</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>AKB10J</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:57.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860033897</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>AKB15</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:57.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860033934</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>AKB20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:57.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034030</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS 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>AK-ACC2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.862Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034054</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS 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>AK-11F3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034078</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS 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>AK-11F6</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034092</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY BONE ACCESS NEEDLE</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>AK08BAC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034115</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY WORKING CANNULA AND EXPANDER</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>AK08WT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034139</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY KIRSCHNER GUIDE</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>AK08KWT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034153</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY KIRSCHNER GUIDE</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>AK08KWP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.767Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860034177</udiDi>
    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>ADITUS KYPHOPLASTY DRILL</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>AK08DR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T04:52:56.747Z</lastUpdated>
  </row>
</eudamedExport>