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<eudamedExport entity="devices">
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    <udiDi>03760124131208</udiDi>
    <basicUdiDi>B-03760124131208</basicUdiDi>
    <tradeName>KIT SOPHY® SM8-400 PRECONNECTE/ BO19-10</tradeName>
    <deviceName>8KIT SOPHY® SM8-400 PRECONNECTE/ BO19-10</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-400-2010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:25.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124131178</udiDi>
    <basicUdiDi>B-03760124131178</basicUdiDi>
    <tradeName>KIT SOPHY® SM8 LOMBO-PERITONEAL PRECONNECTE</tradeName>
    <deviceName>LUMBO-PERITONEAL SOPHY® SM8 KIT PREATTACHED</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:08.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130072</udiDi>
    <basicUdiDi>B-03760124130072</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE DROIT GRADUE 1.3 x 2.2</tradeName>
    <deviceName>Graduated straight ventricular catheter 1.3 x 2.2</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO19-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:07.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130065</udiDi>
    <basicUdiDi>B-03760124130065</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE DROIT STANDARD 1.3 x 2.5</tradeName>
    <deviceName>Standard straight ventricular catheter 1.3 x 2.5</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO19-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:06.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760124130041</udiDi>
    <basicUdiDi>B-03760124130041</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE DROIT PEDIATRIQUE 1.3 x 2.2</tradeName>
    <deviceName>Paediatric straight ventricular catheter 1.3 x 2.2</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO15</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:06.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023823</udiDi>
    <basicUdiDi>B-00813954023823</basicUdiDi>
    <tradeName>KBIO® Dura</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-DU 05 07-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:50.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023816</udiDi>
    <basicUdiDi>B-00813954023816</basicUdiDi>
    <tradeName>KBIO® Dura</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-DU 04 05-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:48.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023809</udiDi>
    <basicUdiDi>B-00813954023809</basicUdiDi>
    <tradeName>KBIO® Dura</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-DU 03 03-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:46.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023793</udiDi>
    <basicUdiDi>B-00813954023793</basicUdiDi>
    <tradeName>KBIO® Dura</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-DU 02 02-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:44.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023786</udiDi>
    <basicUdiDi>B-00813954023786</basicUdiDi>
    <tradeName>KBIO® Dura</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-DU 01 03-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:44.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023779</udiDi>
    <basicUdiDi>B-00813954023779</basicUdiDi>
    <tradeName>KBIO® Dura</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KBI-DU 01 01-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:42.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023380</udiDi>
    <basicUdiDi>B-00813954023380</basicUdiDi>
    <tradeName>RESODURA® matrix suturable</tradeName>
    <deviceName>Collagen Dura Membrane - Suturable</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMS10125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:40.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023373</udiDi>
    <basicUdiDi>B-00813954023373</basicUdiDi>
    <tradeName>RESODURA® matrix suturable</tradeName>
    <deviceName>Collagen Dura Membrane - Suturable</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMS7575</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:38.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023366</udiDi>
    <basicUdiDi>B-00813954023366</basicUdiDi>
    <tradeName>RESODURA® matrix suturable</tradeName>
    <deviceName>Collagen Dura Membrane - Suturable</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMS0505</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:37.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023359</udiDi>
    <basicUdiDi>B-00813954023359</basicUdiDi>
    <tradeName>RESODURA® matrix suturable</tradeName>
    <deviceName>Collagen Dura Membrane - Suturable</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMS2575</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:36.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023342</udiDi>
    <basicUdiDi>B-00813954023342</basicUdiDi>
    <tradeName>RESODURA® matrix suturable</tradeName>
    <deviceName>Collagen Dura Membrane - Suturable</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMS2525</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:33.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023335</udiDi>
    <basicUdiDi>B-00813954023335</basicUdiDi>
    <tradeName>RESODURA® matrix onlay plus</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMOP125175</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:32.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023311</udiDi>
    <basicUdiDi>B-00813954023311</basicUdiDi>
    <tradeName>RESODURA® matrix onlay plus</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMOP7575</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:31.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023328</udiDi>
    <basicUdiDi>B-00813954023328</basicUdiDi>
    <tradeName>RESODURA® matrix onlay plus</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMOP10125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:29.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813954023298</udiDi>
    <basicUdiDi>B-00813954023298</basicUdiDi>
    <tradeName>RESODURA® matrix onlay plus</tradeName>
    <deviceName>Collagen Dural Regeneration Matrix</deviceName>
    <manufacturerName>Collagen Matrix Inc</manufacturerName>
    <manufacturerSrn>US-MF-000015783</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N018099</emdnCode>
    <emdnDescription>ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUMOP2575</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:31:27.267Z</lastUpdated>
  </row>
</eudamedExport>