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<eudamedExport entity="devices">
  <row>
    <udiDi>00810000520459</udiDi>
    <basicUdiDi>B-00810000520459</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Metal Probes</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119005</emdnCode>
    <emdnDescription>PULP VITALITY ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D625</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:12:53.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600251</udiDi>
    <basicUdiDi>50563346ALIGNERREMRUIL5</basicUdiDi>
    <tradeName>OrthoCare Aligner Remover tool</tradeName>
    <deviceName>OrthoCare Aligner Remover tool</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-ART02</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600985</udiDi>
    <basicUdiDi>50563346ALIGNERREMRUIL5</basicUdiDi>
    <tradeName>Orthocare Aligner Remover tool</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-ART02</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:25.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000528134</udiDi>
    <basicUdiDi>081000052MIXINGGUN3HU</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Dispensing Gun 3</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S349</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:47:01.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000526895</udiDi>
    <basicUdiDi>081000052MIXINGGUNVQ</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Dispensing Gun</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S327</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:59.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000526819</udiDi>
    <basicUdiDi>081000052MIXINGGUN2HS</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Unit Dose Dispensing Gun</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S189</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:58.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000526116</udiDi>
    <basicUdiDi>081000052AFS020D6</basicUdiDi>
    <tradeName>AccuFilm</tradeName>
    <deviceName>AccuFilm IV</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020202</emdnCode>
    <emdnDescription>SPRAY AND LIQUID DENTAL CONTACT INDICATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:58.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524280</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName>HedgeHog Burs</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S497</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:54.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000524075</udiDi>
    <basicUdiDi>081000052IMPRESSIONL3</basicUdiDi>
    <tradeName>Cinch®</tradeName>
    <deviceName>Cinch, Mousse &amp; Mach Impression Materials</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S464</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:53.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522040</udiDi>
    <basicUdiDi>081000052WATERFILTERC7</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Water Filter</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12119080</emdnCode>
    <emdnDescription>VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D418</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:52.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520572</udiDi>
    <basicUdiDi>081000052SHEATHR5</basicUdiDi>
    <tradeName>TurboSENSOR®</tradeName>
    <deviceName>Handpiece Sheath</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D576</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:51.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521579</udiDi>
    <basicUdiDi>0081000052CLARITYJ4</basicUdiDi>
    <tradeName>PureClarity™</tradeName>
    <deviceName>PureClarity Water Filter</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D719</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:23:45.087Z</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>D572</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:40.668Z</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>D718</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:40.472Z</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>S436</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.883Z</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>S498</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.834Z</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>S499</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.807Z</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>S500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.786Z</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>S501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.764Z</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>S502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.738Z</lastUpdated>
  </row>
</eudamedExport>