<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08033860001476</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName>VERTEBROPLASTY SYSTEMS</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1312002C-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:21:37.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860001384</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName>VERTEBROPLASTY SYSTEMS</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1112002C-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:11:09.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860028008</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERT-STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VKM-1115-AMS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:58:25.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860028916</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROPLASTIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRVT1110200CBP-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:58:24.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860029661</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROPLASTIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRVT1310200CBP-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:58:22.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860030742</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROPLASTIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRVT1515200CBP-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:58:20.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860032579</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROPLASTIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRVT1510200CBP-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:49:18.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860032722</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROSTEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KMFVT1110025C-A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:49:18.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860038038</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERT-STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VKM-1112</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:49:00.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860038908</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERT-STEEL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VKM-1115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T08:48:58.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860018344</udiDi>
    <basicUdiDi>B-08033860018344</basicUdiDi>
    <tradeName>VERTEBROPLASTIC</tradeName>
    <deviceName>VERTEBROPLASTIC</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KRVT1312200CB-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T19:26:04.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964725462</udiDi>
    <basicUdiDi>805896472vertebrokitF8</basicUdiDi>
    <tradeName>08058964725462</tradeName>
    <deviceName>Vertebroplasty Kit</deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VK01 11 150 5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:10:03.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033860047252</udiDi>
    <basicUdiDi>8033860VERTFT05CL</basicUdiDi>
    <tradeName>VERTEBROPLASTIC</tradeName>
    <deviceName>VERTEBROPLASTY SYSTEMS</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SR323SU</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:47:56.344Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850068519040</udiDi>
    <basicUdiDi>0850068519IO70XVL</basicUdiDi>
    <tradeName>SAM IO ® Needle - 15mm</tradeName>
    <deviceName>SAM IO Needle</deviceName>
    <manufacturerName>ZIEN Medical Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000004717</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IO705W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:31:06.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>60801902203214</udiDi>
    <basicUdiDi>08019020000000000000284L2</basicUdiDi>
    <tradeName>FAST1 STERNAL IO DEV STERILE</tradeName>
    <deviceName>FAST 1 Sternal Intraosseous Device</deviceName>
    <manufacturerName>Teleflex Medical</manufacturerName>
    <manufacturerSrn>IE-MF-000015868</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-0042RTR</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:34:44.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705034209388</udiDi>
    <basicUdiDi>0705034a0009365</basicUdiDi>
    <tradeName>CONFIDENCE SPINAL CEMENT SYSTEM</tradeName>
    <deviceName>Confidence Biopsy Needle / Introducer Needle</deviceName>
    <manufacturerName>Medos International SARL</manufacturerName>
    <manufacturerSrn>CH-MF-000014268</manufacturerSrn>
    <authorisedRepresentativeName>DePuy Ireland UC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000009328</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>283901913</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T23:33:46.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802526PQ</udiDi>
    <basicUdiDi>B-802526PQ</basicUdiDi>
    <tradeName>D-802526PQ</tradeName>
    <deviceName>AGO PER VERTEBROPLASTICA 15G 15cm CON HUB IN METALLO</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802526</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:06.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802525PN</udiDi>
    <basicUdiDi>B-802525PN</basicUdiDi>
    <tradeName>D-802525PN</tradeName>
    <deviceName>AGO PER VERTEBROPLASTICA 15G 10cm CON HUB IN METALLO</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802525</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:05.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802524PL</udiDi>
    <basicUdiDi>B-802524PL</basicUdiDi>
    <tradeName>D-802524PL</tradeName>
    <deviceName>AGO PER VERTEBROPLASTICA 13G 15cm CON HUB IN METALLO</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802524</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:01.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-802523PJ</udiDi>
    <basicUdiDi>B-802523PJ</basicUdiDi>
    <tradeName>D-802523PJ</tradeName>
    <deviceName>AGO PER VERTEBROPLASTICA 13G 10cm CON HUB IN METALLO</deviceName>
    <manufacturerName>MED ITALIA BIOMEDICA S.R.L</manufacturerName>
    <manufacturerSrn>IT-MF-000025272</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A019011</emdnCode>
    <emdnDescription>INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>802523</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:34:00.705Z</lastUpdated>
  </row>
</eudamedExport>