<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07798034461203</udiDi>
    <basicUdiDi>B-07798034461203</basicUdiDi>
    <tradeName>Subiton Craneoplastías</tradeName>
    <deviceName>CEMENTOS PARA CRANEOPLASTÍA</deviceName>
    <manufacturerName>Laboratorios SL S.A.</manufacturerName>
    <manufacturerSrn>AR-MF-000023153</manufacturerSrn>
    <authorisedRepresentativeName>Synergie Ingénierie Médicale</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000001802</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880120</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:18:42.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177043084</udiDi>
    <basicUdiDi>376017704B28DE</basicUdiDi>
    <tradeName>High V+ - Spinal cement system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T040321K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177043114</udiDi>
    <basicUdiDi>376017704B24D6</basicUdiDi>
    <tradeName>S5 Injector</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T060418</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177043121</udiDi>
    <basicUdiDi>376017704B23D4</basicUdiDi>
    <tradeName>Mini-Malax adapted to S5 Injector</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T060419</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177043138</udiDi>
    <basicUdiDi>376017704B23D4</basicUdiDi>
    <tradeName>Mini-Malax adapted to High Viscosity Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T060420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045217</udiDi>
    <basicUdiDi>376017704B33D7</basicUdiDi>
    <tradeName>PUREKIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T060425</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.659Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045330</udiDi>
    <basicUdiDi>376017704B35DB</basicUdiDi>
    <tradeName>PUREKIT GUN LV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T060425LV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177045361</udiDi>
    <basicUdiDi>376017704B34D9</basicUdiDi>
    <tradeName>PUREKIT GUN MV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T060425MV</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177047013</udiDi>
    <basicUdiDi>376017704B24D6</basicUdiDi>
    <tradeName>VertoCure Cement Delivery System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80E1AS0005M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177047020</udiDi>
    <basicUdiDi>376017704B24D6</basicUdiDi>
    <tradeName>OSTEOGUN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCF-1020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177047396</udiDi>
    <basicUdiDi>376017704B28DE</basicUdiDi>
    <tradeName>NuVasive Maximum Viscosity - Spinal Cement System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10001127</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177047402</udiDi>
    <basicUdiDi>376017704B25D8</basicUdiDi>
    <tradeName>Max V Cement Injection System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10001156</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177047426</udiDi>
    <basicUdiDi>376017704B23D4</basicUdiDi>
    <tradeName>Max V cement mixing system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000001224</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10001157</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177049284</udiDi>
    <basicUdiDi>376017704B28DE</basicUdiDi>
    <tradeName>NEO V+ - Spinal cement system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T040332</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177049413</udiDi>
    <basicUdiDi>376017704B28DE</basicUdiDi>
    <tradeName>INTROX® HighV - Spinal cement system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM-IN3001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760177049437</udiDi>
    <basicUdiDi>376017704B28DE</basicUdiDi>
    <tradeName>VV+ - Spinal Cement System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TEKNIMED SAS</manufacturerName>
    <manufacturerSrn>FR-PR-000001226</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T040333K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T06:10:29.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720897</udiDi>
    <basicUdiDi>B-06951233720897</basicUdiDi>
    <tradeName>Bone Cement Mixing System</tradeName>
    <deviceName>Bone Cement Mixing System</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5050166</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:32.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720736</udiDi>
    <basicUdiDi>B-06951233720736</basicUdiDi>
    <tradeName>Bone Cement Mixing System</tradeName>
    <deviceName>Bone Cement Mixing System</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL006-01BE(CM062)</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:31.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720644</udiDi>
    <basicUdiDi>B-06951233720644</basicUdiDi>
    <tradeName>Bone Cement Mixing System</tradeName>
    <deviceName>Bone Cement Mixing System</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:23.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951233720552</udiDi>
    <basicUdiDi>B-06951233720552</basicUdiDi>
    <tradeName>Bone Cement Mixing System</tradeName>
    <deviceName>Bone Cement Mixing System</deviceName>
    <manufacturerName>Guangzhou Clean Medical Products Manufacturing Corp.</manufacturerName>
    <manufacturerSrn>CN-MF-000008926</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL006-01BEH</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:40:22.063Z</lastUpdated>
  </row>
</eudamedExport>