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<eudamedExport entity="devices">
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    <udiDi>00810000522750</udiDi>
    <basicUdiDi>B-00810000522750</basicUdiDi>
    <tradeName>GentleCLEAN™</tradeName>
    <deviceName>Wrench for Attaching GentleCLEAN™ Tips</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSG30GCW</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:25.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522712</udiDi>
    <basicUdiDi>B-00810000522712</basicUdiDi>
    <tradeName>GentleCLEAN™</tradeName>
    <deviceName>GentleCLEAN™ 30khz Soft-Grip Ultrasonic Insert</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSG30GC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:24.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522705</udiDi>
    <basicUdiDi>B-00810000522705</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>30k Right-Curved Perio Insert</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPR30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:23.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522682</udiDi>
    <basicUdiDi>B-00810000522682</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>30k Left-Curved Perio Insert</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPL30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:22.830Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522668</udiDi>
    <basicUdiDi>B-00810000522668</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Perio 30k Internal Water Scaler Insert</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPI30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:18.835Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522651</udiDi>
    <basicUdiDi>B-00810000522651</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Perio 25k Internal Water Scaler Insert</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DPI25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:18.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522545</udiDi>
    <basicUdiDi>B-00810000522545</basicUdiDi>
    <tradeName>Comfort Grip™</tradeName>
    <deviceName>COMFORT GRIP™ 30K TRIPLE BEND INSERT (Standard Flow)</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DCG30Tri</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:17.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522521</udiDi>
    <basicUdiDi>B-00810000522521</basicUdiDi>
    <tradeName>Comfort Grip™</tradeName>
    <deviceName>COMFORT-GRIP™ 30K UNIVERSAL SLIM INSERT (Standard Flow)</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DCG30SLIM</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:16.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000522514</udiDi>
    <basicUdiDi>B-00810000522514</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Beavertail 30k Internal Water Scaler</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DBI30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:12.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521067</udiDi>
    <basicUdiDi>B-00810000521067</basicUdiDi>
    <tradeName>TurboSENSOR +™</tradeName>
    <deviceName>TurboSENSOR +™ Detachable 30K (Lilac)</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D660-P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:11.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521050</udiDi>
    <basicUdiDi>B-00810000521050</basicUdiDi>
    <tradeName>TurboSENSOR +™</tradeName>
    <deviceName>TurboSENSOR +™ Detachable 30K (Tangerine)</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D660-O</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:10.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521043</udiDi>
    <basicUdiDi>B-00810000521043</basicUdiDi>
    <tradeName>TurboSENSOR +™</tradeName>
    <deviceName>TurboSENSOR +™ Detachable 30K (Midnight Blue)</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D660-N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:10.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000521036</udiDi>
    <basicUdiDi>B-00810000521036</basicUdiDi>
    <tradeName>TurboSENSOR +™</tradeName>
    <deviceName>TurboSENSOR +™ Detachable 30K (Electric Blue )</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D660-B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:06.033Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520985</udiDi>
    <basicUdiDi>B-00810000520985</basicUdiDi>
    <tradeName>TurboSENSOR +™</tradeName>
    <deviceName>TurboSENSOR +™ Detachable 30K (Pearl)</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D660</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:05.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520909</udiDi>
    <basicUdiDi>B-00810000520909</basicUdiDi>
    <tradeName>TurboSENSOR +™</tradeName>
    <deviceName>TurboSENSOR +™ 30K Detachable Handpiece</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D722</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:05.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520862</udiDi>
    <basicUdiDi>B-00810000520862</basicUdiDi>
    <tradeName>Digitest™</tradeName>
    <deviceName>Digitest 3</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>D655</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:13:03.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520688</udiDi>
    <basicUdiDi>B-00810000520688</basicUdiDi>
    <tradeName>Digitest™</tradeName>
    <deviceName>Digitest™ 3 Pulp Vitality Tester</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>D655E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:12:59.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520527</udiDi>
    <basicUdiDi>B-00810000520527</basicUdiDi>
    <tradeName>TurboSENSOR®</tradeName>
    <deviceName>TurboSENSOR</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>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D560-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:12:58.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520480</udiDi>
    <basicUdiDi>B-00810000520480</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Precision Probe Set</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>D636</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:12:58.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810000520473</udiDi>
    <basicUdiDi>B-00810000520473</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Ground Clip and Lead Wire</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>D631GC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:12:57.227Z</lastUpdated>
  </row>
</eudamedExport>