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<eudamedExport entity="devices">
  <row>
    <udiDi>20810000525168</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>DryZ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S191</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:56.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>30810000525141</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>DryZ®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:16:50.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000526116</udiDi>
    <basicUdiDi>081000052AFS020D6</basicUdiDi>
    <tradeName>AccuFilm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01020202</emdnCode>
    <emdnDescription>SPRAY AND LIQUID DENTAL CONTACT INDICATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:14:14.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524341</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:51.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524334</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:49.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524327</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:48.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524310</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:47.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524303</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:46.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524297</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:45.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524280</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:44.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524143</udiDi>
    <basicUdiDi>081000052IMPRESSIONL3</basicUdiDi>
    <tradeName>Blu-Mousse®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:43.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524075</udiDi>
    <basicUdiDi>081000052IMPRESSIONL3</basicUdiDi>
    <tradeName>Cinch®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:42.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521647</udiDi>
    <basicUdiDi>0081000052CLARITYJ4</basicUdiDi>
    <tradeName>PureClarity™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:28.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521579</udiDi>
    <basicUdiDi>0081000052CLARITYJ4</basicUdiDi>
    <tradeName>PureClarity™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:27.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520848</udiDi>
    <basicUdiDi>081000052SHEATHR5</basicUdiDi>
    <tradeName>TurboVUE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:18.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520572</udiDi>
    <basicUdiDi>081000052SHEATHR5</basicUdiDi>
    <tradeName>TurboSENSOR®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-05T11:13:16.566Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000525710</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>Simplee®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-02T14:37:46.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000528134</udiDi>
    <basicUdiDi>081000052MIXINGGUN3HU</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T05:42:41.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000527595</udiDi>
    <basicUdiDi>081000052MIXINGGUNVQ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T05:42:39.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000526949</udiDi>
    <basicUdiDi>081000052MIXINGGUNVQ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-30T05:42:38.768Z</lastUpdated>
  </row>
</eudamedExport>