<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07798034460947</udiDi>
    <basicUdiDi>B-07798034460947</basicUdiDi>
    <tradeName>Set Subiton VTP INTEGRAL</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884094</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:33.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460930</udiDi>
    <basicUdiDi>B-07798034460930</basicUdiDi>
    <tradeName>Set Subiton VTP INTEGRAL</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884093</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:29.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460923</udiDi>
    <basicUdiDi>B-07798034460923</basicUdiDi>
    <tradeName>Set Subiton VTP INTEGRAL</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884092</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:28.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460916</udiDi>
    <basicUdiDi>B-07798034460916</basicUdiDi>
    <tradeName>Set Subiton VTP INTEGRAL</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884091</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:27.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460886</udiDi>
    <basicUdiDi>B-07798034460886</basicUdiDi>
    <tradeName>Set Subiton VTP</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884088</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:26.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460879</udiDi>
    <basicUdiDi>B-07798034460879</basicUdiDi>
    <tradeName>Set Subiton VTP</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884087</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:22.650Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460862</udiDi>
    <basicUdiDi>B-07798034460862</basicUdiDi>
    <tradeName>Set Subiton VTP</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884086</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:21.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798034460855</udiDi>
    <basicUdiDi>B-07798034460855</basicUdiDi>
    <tradeName>Set Subiton VTP</tradeName>
    <deviceName>Sistema estéril de aplicación de cemento para vertebroplastía</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</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>884085</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:08:21.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964727824</udiDi>
    <basicUdiDi>805896472vertebrokitF8</basicUdiDi>
    <tradeName>08058964727824</tradeName>
    <deviceName></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 11 120 5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:31.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964727909</udiDi>
    <basicUdiDi>805896472vertebrokitF8</basicUdiDi>
    <tradeName>08058964727909</tradeName>
    <deviceName></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 13 120 5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:20.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964725486</udiDi>
    <basicUdiDi>805896472vertebrokitF8</basicUdiDi>
    <tradeName>08058964725486</tradeName>
    <deviceName></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 13 150 5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:19.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045743</udiDi>
    <basicUdiDi>376017704B32D5</basicUdiDi>
    <tradeName>Vertebroplasty Needle 11G</tradeName>
    <deviceName>Vertebroplasty Needles</deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</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>T060411</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:16:25.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045750</udiDi>
    <basicUdiDi>376017704B32D5</basicUdiDi>
    <tradeName>Vertebroplasty Needle 11G &amp; Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</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>T060411B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045767</udiDi>
    <basicUdiDi>376017704B32D5</basicUdiDi>
    <tradeName>Vertebroplasty Needle 13G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</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>T060413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045774</udiDi>
    <basicUdiDi>376017704B32D5</basicUdiDi>
    <tradeName>Vertebroplasty Needle 13G &amp; Biopsy Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</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>T060413B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705034209395</udiDi>
    <basicUdiDi>0705034a0009365</basicUdiDi>
    <tradeName>CONFIDENCE SPINAL CEMENT SYSTEM</tradeName>
    <deviceName></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>283901915</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:37.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705034209401</udiDi>
    <basicUdiDi>0705034a0009365</basicUdiDi>
    <tradeName>CONFIDENCE SPINAL CEMENT SYSTEM</tradeName>
    <deviceName></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>283902411</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:36.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705034209418</udiDi>
    <basicUdiDi>0705034a0009365</basicUdiDi>
    <tradeName>CONFIDENCE SPINAL CEMENT SYSTEM</tradeName>
    <deviceName></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>283902413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:36.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705034209425</udiDi>
    <basicUdiDi>0705034a0009365</basicUdiDi>
    <tradeName>CONFIDENCE SPINAL CEMENT SYSTEM</tradeName>
    <deviceName></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>283902510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:36.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>10705034209432</udiDi>
    <basicUdiDi>0705034a0009365</basicUdiDi>
    <tradeName>CONFIDENCE SPINAL CEMENT SYSTEM</tradeName>
    <deviceName></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>283902611</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:36.894Z</lastUpdated>
  </row>
</eudamedExport>