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<eudamedExport entity="devices">
  <row>
    <udiDi>05060417202751</udiDi>
    <basicUdiDi>506041720RETRACTOR-SUTE</basicUdiDi>
    <tradeName>Shea Aural Specula 4mm PK 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P60-501</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:25.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060417202775</udiDi>
    <basicUdiDi>506041720RETRACTOR-SUTE</basicUdiDi>
    <tradeName>Shea Aural Specula 6mm PK 100</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P60-503</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:25.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060417203000</udiDi>
    <basicUdiDi>506041720PROBE-STMP</basicUdiDi>
    <tradeName>Formby Cerumen Scoop and Hook</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TE10-198S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:24.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060417203239</udiDi>
    <basicUdiDi>506041720RETRACTOR-SUTE</basicUdiDi>
    <tradeName>Magauran Plate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>TE15-158</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:24.792Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060417203277</udiDi>
    <basicUdiDi>506041720PROBE-RUMN</basicUdiDi>
    <tradeName>Negus Pusher</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>KNOT PUSHERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E15-121</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:24.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060417203789</udiDi>
    <basicUdiDi>506041720PROBE-RUMN</basicUdiDi>
    <tradeName>Macdonald Dissector D/E 185mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sheffmed Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000004158</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>GENERAL SURGERY DISSECTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G25-100</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-25T02:41:24.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0010200</udiDi>
    <basicUdiDi>++EPRC12140102BC</basicUdiDi>
    <tradeName>otosil IS-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0010200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:23.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0011000</udiDi>
    <basicUdiDi>++EPRC12140102BC</basicUdiDi>
    <tradeName>otosil PS-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0011000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:23.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0034160</udiDi>
    <basicUdiDi>++EPRC12140103BE</basicUdiDi>
    <tradeName>otosil SL-1 | MSI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0034160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:20.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>EPRCA0034151</udiDi>
    <basicUdiDi>++EPRC12140103BE</basicUdiDi>
    <tradeName>otosil SL-1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>pro3dure medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000000024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A0034151</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T19:46:20.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420615710783</udiDi>
    <basicUdiDi>642061571340044AQ</basicUdiDi>
    <tradeName>Otocur korvatipat 25 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340044</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:54.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>06420615710868</udiDi>
    <basicUdiDi>642061571340044AQ</basicUdiDi>
    <tradeName>YA Korvasuihke 30 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Galena Pharma Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>34004/425116</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T14:35:54.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100110237</udiDi>
    <basicUdiDi>643210REM001UD</basicUdiDi>
    <tradeName>Remo-Wax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-MF-000001595</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163949</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:40.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100110220</udiDi>
    <basicUdiDi>643210RPP001YT</basicUdiDi>
    <tradeName>Remo-Wax 10ml + gumow gruszka</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-PR-000001596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163552</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:38.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100107190</udiDi>
    <basicUdiDi>643210REM001UD</basicUdiDi>
    <tradeName>Remo-wax øredråber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-MF-000001595</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163697</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:37.747Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100107091</udiDi>
    <basicUdiDi>643210RPP001YT</basicUdiDi>
    <tradeName>Remo-wax øredråber med sprøjte</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-PR-000001596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163676</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:36.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100106285</udiDi>
    <basicUdiDi>643210RPP001YT</basicUdiDi>
    <tradeName>Remo-Wax korvatipat 10 ml pakkaus sisältää korvapumpun</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-PR-000001596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163523</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:35.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100106278</udiDi>
    <basicUdiDi>643210REM001UD</basicUdiDi>
    <tradeName>Remo-Wax korvatipat</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-MF-000001595</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163521</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:34.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100106261</udiDi>
    <basicUdiDi>643210REM001UD</basicUdiDi>
    <tradeName>Revaxör örondroppar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-MF-000001595</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163645</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:32.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>06432100106254</udiDi>
    <basicUdiDi>643210RPP001YT</basicUdiDi>
    <tradeName>Revaxör örondroppar med sköljblåsa</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Orion Oyj</manufacturerName>
    <manufacturerSrn>FI-PR-000001596</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q030499</emdnCode>
    <emdnDescription>OTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>163655</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:06:31.765Z</lastUpdated>
  </row>
</eudamedExport>