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<eudamedExport entity="devices">
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    <udiDi>05060639240524</udiDi>
    <basicUdiDi>506063924HEROGAUNTLETZ9</basicUdiDi>
    <tradeName>Hero Gauntlet</tradeName>
    <deviceName>Hero Gauntlet</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:35.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060639240005</udiDi>
    <basicUdiDi>506063924HeroArmFP</basicUdiDi>
    <tradeName>Hero Arm</tradeName>
    <deviceName>Hero Arm</deviceName>
    <manufacturerName>Open Bionics Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000032650</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090499</emdnCode>
    <emdnDescription>HAND PROSTHESES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4001004</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:29:32.471Z</lastUpdated>
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  <row>
    <udiDi>05060183095793</udiDi>
    <basicUdiDi>5060183090035S</basicUdiDi>
    <tradeName>05060183095793</tradeName>
    <deviceName>Osteotec SFI Instruments</deviceName>
    <manufacturerName>Osteotec Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000019832</manufacturerSrn>
    <authorisedRepresentativeName>Osteotec Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000037895</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090480</emdnCode>
    <emdnDescription>HAND PROSTHESES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSTF-Ins</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:07:42.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254162</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Konos, DM - Cementless cup (Ti+HA), D10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413231</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:08.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254155</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Konos, DM - Cementless cup (Ti+HA), D9</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413230</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:07.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254148</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere, DM - Cementless cup (Ti+HA), D10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413229</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:06.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254131</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere, DM - Cementless cup (Ti+HA), D9</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413228</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:56:05.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254124</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Konos, DM - Cementless cup (Ti), D10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413227</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:55:59.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254117</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Konos, DM - Cementless cup (Ti), D9</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413226</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:55:57.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254100</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere, DM - Cementless cup (Ti), D10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413225</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:55:56.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254094</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere, DM - Cementless cup (Ti), D9</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413224</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:55:55.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254087</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere - Cementless cup (Ti), D10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413223</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:55:49.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602254070</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere - Cementless cup (Ti), D9</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413222</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:55:48.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253660</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Trapezium insert, TR, PE-E, 9/5</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413219</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:56.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253653</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Trapezium insert, TR, PE-E, 10/5</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413220</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:55.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253646</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Trapezium insert, TR, PE-E, 11/5</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413221</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:48.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253639</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Cemented cup with offset, T/II, PE-E, 5/10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413218</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:47.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253622</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Sphere - Cemented cup, PE-E, 5/10</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413217</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:45.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253615</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - Insert, T/III, for head, PE-E, D5</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413216</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:44.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>08592602253608</udiDi>
    <basicUdiDi>859260207001FZ</basicUdiDi>
    <tradeName>ELiS - DM - Valgus neck 15°/Ante-R, PE-E, 7.7/18</tradeName>
    <deviceName>REPLACEMENT OF PART OF THE UPPER LIMB - Replacement of Trapeziometacarpal Joint</deviceName>
    <manufacturerName>BEZNOSKA, s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000000543</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P090404</emdnCode>
    <emdnDescription>HAND PROSTHESES TRAPEZIO-METACARPAL COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>413215</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T13:54:38.741Z</lastUpdated>
  </row>
</eudamedExport>