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<eudamedExport entity="devices">
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    <udiDi>D-007A(II)/RPN2.5*130ZW</udiDi>
    <basicUdiDi>B-007A(II)/RPN2.5*130ZW</basicUdiDi>
    <tradeName>FWS-007A(II) Rotary Puncture Needle ϕ2.5×130</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>2026-07-04T15:34:12.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(II)/RPN2.5*100ZM</udiDi>
    <basicUdiDi>B-007A(II)/RPN2.5*100ZM</basicUdiDi>
    <tradeName>FWS-007A(II) Rotary Puncture Needle ϕ2.5×100</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>2026-07-04T15:34:11.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(II)/BCSRS</udiDi>
    <basicUdiDi>B-007A(II)/BCSRS</basicUdiDi>
    <tradeName>FWS-007A(II) Bone Cement Syringe ϕ20.0×105</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>2026-07-04T15:34:07.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(I)/LPN3.2*130UZ</udiDi>
    <basicUdiDi>B-007A(I)/LPN3.2*130UZ</basicUdiDi>
    <tradeName>FWS-007A(I) Locking Puncture Needle ϕ3.2×130</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>2026-07-04T15:34:07.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(I)/LPN3.2*100UQ</udiDi>
    <basicUdiDi>B-007A(I)/LPN3.2*100UQ</basicUdiDi>
    <tradeName>FWS-007A(I) Locking Puncture Needle ϕ3.2×100</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>2026-07-04T15:34:06.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(I)/LPN2.5*130VH</udiDi>
    <basicUdiDi>B-007A(I)/LPN2.5*130VH</basicUdiDi>
    <tradeName>FWS-007A(I) Locking Puncture Needle ϕ2.5×130</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>2026-07-04T15:34:05.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(I)/LPN2.5*100V8</udiDi>
    <basicUdiDi>B-007A(I)/LPN2.5*100V8</basicUdiDi>
    <tradeName>FWS-007A(I) Locking Puncture Needle ϕ2.5×100</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>2026-07-04T15:34:01.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-007A(I)/BCST4</udiDi>
    <basicUdiDi>B-007A(I)/BCST4</basicUdiDi>
    <tradeName>FWS-007A(I) Bone Cement Syringe ϕ20.0×105</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>2026-07-04T15:34:00.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08058964724625</udiDi>
    <basicUdiDi>805896472kit3W</basicUdiDi>
    <tradeName>V-MIX 03</tradeName>
    <deviceName></deviceName>
    <manufacturerName>G21 S.R.L.</manufacturerName>
    <manufacturerSrn>IT-PR-000041137</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>800047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:44:08.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683604114193</udiDi>
    <basicUdiDi>8683604114D04A2</basicUdiDi>
    <tradeName>Morpho Bone Cement Mixer</tradeName>
    <deviceName>Bone Cement Mixer</deviceName>
    <manufacturerName>MACCORE MEDİKAL İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000036830</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>BCM01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:14:40.184Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000475</udiDi>
    <basicUdiDi>8682024KFP290326SY</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM BONE FILLER BONE FILLING CANNULA</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290326</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:39.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000451</udiDi>
    <basicUdiDi>8682024KFP290324SU</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM BONE INTERVENTION KIT FIRST ENTRY NEEDLE</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290324</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:38.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000444</udiDi>
    <basicUdiDi>8682024KFP290323SS</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM PRECISION SURGICAL DRILL</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290323</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:35.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000437</udiDi>
    <basicUdiDi>8682024KFP290322SQ</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM WORKING CANNULA</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KFP290322</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:34.298Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000420</udiDi>
    <basicUdiDi>8682024VTBK290321S6</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM VTB KIT -- VERTEBROPLASTY BONE INTERVENTION KIT FIRST ENTRY NEEDLE</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTBK290321</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:33.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000413</udiDi>
    <basicUdiDi>8682024VTBK290320S4</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM VTB KIT -- VERTEBROPLASTY SPINE KIT</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VTBK290320</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:31.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000352</udiDi>
    <basicUdiDi>8682024MIX180123Z7</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM Mix Cement Mixing Kit with Pressure- Vacuum</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIX180123</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:21.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682024000345</udiDi>
    <basicUdiDi>8682024MIX180122Z5</basicUdiDi>
    <tradeName>OGM®</tradeName>
    <deviceName>OGM Mix Cement Mixing Kit with Pressure</deviceName>
    <manufacturerName>Ormed Grup Medikal Turizm Sağlık Hizmetleri Sanayi ve Ticari LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000021263</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIX180122</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:37:20.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>08031497003771</udiDi>
    <basicUdiDi>80314970703P7</basicUdiDi>
    <tradeName>Mendec Kypho Set Bilateral 10 mm</tradeName>
    <deviceName>Mendec Kypho Set Bilateral</deviceName>
    <manufacturerName>Tecres S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027511</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASB028A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:11.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08031497003658</udiDi>
    <basicUdiDi>80314970702P5</basicUdiDi>
    <tradeName>Mendec Kypho Set Monolateral 10 mm</tradeName>
    <deviceName>Mendec Kypho Set Monolateral</deviceName>
    <manufacturerName>Tecres S.p.A.</manufacturerName>
    <manufacturerSrn>IT-PR-000027511</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P099002</emdnCode>
    <emdnDescription>ORTHOPAEDIC CEMENT PREPARATION AND APPLICATION DEVICES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASB026A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:44:10.217Z</lastUpdated>
  </row>
</eudamedExport>