<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03700448200228</udiDi>
    <basicUdiDi>B-03700448200228</basicUdiDi>
    <tradeName>Eurofix Gun</tradeName>
    <deviceName>Eurofix Gun: orthopecic cement</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880314</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:51.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200211</udiDi>
    <basicUdiDi>B-03700448200211</basicUdiDi>
    <tradeName>Eurofix G</tradeName>
    <deviceName>Eurofix G: ortopedic cement with gentamicin</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880213</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:49.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200204</udiDi>
    <basicUdiDi>B-03700448200204</basicUdiDi>
    <tradeName>Eurofix RO</tradeName>
    <deviceName>Eurofix RO: orthopedic cement</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880013</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:47.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200150</udiDi>
    <basicUdiDi>B-03700448200150</basicUdiDi>
    <tradeName>CEMTEQ BVG</tradeName>
    <deviceName>CEMTEQ BVG:orthopedic cement with gentamicin</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880415</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:45.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200143</udiDi>
    <basicUdiDi>B-03700448200143</basicUdiDi>
    <tradeName>CEMTEQ BV</tradeName>
    <deviceName>CEMTEQ BV</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880315</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:44.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200136</udiDi>
    <basicUdiDi>B-03700448200136</basicUdiDi>
    <tradeName>Cemteq G</tradeName>
    <deviceName>Cemteq G: orthopedic cement with gentamicin</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880215</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:43.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200129</udiDi>
    <basicUdiDi>B-03700448200129</basicUdiDi>
    <tradeName>CEMTEQ</tradeName>
    <deviceName>CEMTEQ: orthopedic cement</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880005</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:40.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200112</udiDi>
    <basicUdiDi>B-03700448200112</basicUdiDi>
    <tradeName>Biofix VTP</tradeName>
    <deviceName>Biofix cement for Vertebroplasty</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880825</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:39.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200037</udiDi>
    <basicUdiDi>B-03700448200037</basicUdiDi>
    <tradeName>Biofix 3G</tradeName>
    <deviceName>Biofix 3G: orthopedic cements with gentamicin</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880425</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:38.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200020</udiDi>
    <basicUdiDi>B-03700448200020</basicUdiDi>
    <tradeName>Biofix 3</tradeName>
    <deviceName>Biofix 3 orthopedic cement</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880325</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:36.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200013</udiDi>
    <basicUdiDi>B-03700448200013</basicUdiDi>
    <tradeName>Biofix 1G</tradeName>
    <deviceName>Biofix 1G: orthopedic cement with gentamicin</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880225</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:34.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700448200006</udiDi>
    <basicUdiDi>B-03700448200006</basicUdiDi>
    <tradeName>Biofix 1</tradeName>
    <deviceName>Biofix 1: orthopedic cement</deviceName>
    <manufacturerName>SYNERGIE INGENIERIE MEDICALE</manufacturerName>
    <manufacturerSrn>FR-MF-000001635</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099001</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>880025</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T15:30:32.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/TWV7W</udiDi>
    <basicUdiDi>B-009/TWV7W</basicUdiDi>
    <tradeName>FWS-009-20 Three-way valve</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:12.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/TCQW</udiDi>
    <basicUdiDi>B-009/TCQW</basicUdiDi>
    <tradeName>FWS-009-20 Thread casing</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:11.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/PRRG</udiDi>
    <basicUdiDi>B-009/PRRG</basicUdiDi>
    <tradeName>FWS-009-20 Push Rod</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:09.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/PGQS</udiDi>
    <basicUdiDi>B-009/PGQS</basicUdiDi>
    <tradeName>FWS-009-20 Pressure guage</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:07.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/PGN</udiDi>
    <basicUdiDi>B-009/PGN</basicUdiDi>
    <tradeName>FWS-009-20 The piston</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:05.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/OTT6Q</udiDi>
    <basicUdiDi>B-009/OTT6Q</basicUdiDi>
    <tradeName>FWS-009-20 Outside the tube</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:05.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/JGA</udiDi>
    <basicUdiDi>B-009/JGA</basicUdiDi>
    <tradeName>FWS-009-20 Joint</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:03.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-009/ERQF</udiDi>
    <basicUdiDi>B-009/ERQF</basicUdiDi>
    <tradeName>FWS-009-20 The elastic rod</tradeName>
    <deviceName>Vertebroplasty auxiliary instrument</deviceName>
    <manufacturerName>Chongqing FWS Medical Device Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000008972</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:01.043Z</lastUpdated>
  </row>
</eudamedExport>