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<eudamedExport entity="devices">
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    <udiDi>05060111783129</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Air Water Syringe Sleeve 3/4 Sealed - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH135</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783136</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Sticky Film Clear - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783143</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Sticky Film Blue- Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH101</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783150</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Half Chair Cover  - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH146</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783167</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Full Chair Cover  - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH145</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783174</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Headrest Cover - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH147</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783181</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Digital X-Ray Sensor Cover - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH150</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783198</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>X-Ray Head Cover- Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH125</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783204</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Tubing Sleeve Large- Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH152</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783211</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Tubing Sleeve Small  - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH154</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783228</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Tray Sleeve  - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH120</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060111783235</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Curing Light Gun Sleeve  - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH130</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978726485446</udiDi>
    <basicUdiDi>69787264811-30001XW</basicUdiDi>
    <tradeName>Bite Block Cover</tradeName>
    <deviceName>Barrier Film and Sleeves</deviceName>
    <manufacturerName>Jiangsu Yabaobao Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048665</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-30116</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:43:38.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978726485453</udiDi>
    <basicUdiDi>69787264811-30001XW</basicUdiDi>
    <tradeName>Bite Block Cover</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu Yabaobao Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000048665</manufacturerSrn>
    <authorisedRepresentativeName>Kingsmead Service B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002066</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11-30100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T03:35:03.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>16975284216472</udiDi>
    <basicUdiDi>6975284211004AF</basicUdiDi>
    <tradeName>STERILE INSTRUMENT COVER</tradeName>
    <deviceName>STERILE INSTRUMENT COVER</deviceName>
    <manufacturerName>Hony Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008239</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Y87111</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:51:59.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260434710272</udiDi>
    <basicUdiDi>426043471EQPCoversPP-GFD</basicUdiDi>
    <tradeName>SonoGuard Set</tradeName>
    <deviceName>Procedure Pack - Equipment Cover and Gel</deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000035547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.120-G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:44:38.962Z</lastUpdated>
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  <row>
    <udiDi>04260434710043</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName>Equipment Cover</deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:44:38.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260434710005</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:11.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260434710029</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:01.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260434710081</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.20.180.040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:38:47.762Z</lastUpdated>
  </row>
</eudamedExport>