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<eudamedExport entity="devices">
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    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>PoloDent Ultrasonic Cleaner Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>830007</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:57.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850785</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Bossklein ULTRAbio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOS9794</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:56.060Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850778</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Bossklein ULTRAbio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOS9788</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:55.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850693</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Douromed detergente de ultrasons</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD9794</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:54.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850679</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Douromed detergente de ultrasons</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD9788</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:53.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850570</udiDi>
    <basicUdiDi>1506049385Oil8N</basicUdiDi>
    <tradeName>Douromed óleo lubrificante universal</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD9777</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:52.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850402</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>CBM Ultrasonic Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBM9788</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:51.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850310</udiDi>
    <basicUdiDi>1506049385Oil8N</basicUdiDi>
    <tradeName>Topdental Universal Handpiece Oil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOP0037</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:50.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850235</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Topdent Hygiene Enzymatic Ultrasonic Cleaner Concentrate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>734343</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:49.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850211</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>ID Limpiador Ultrasonidos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIB137</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:48.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493850143</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Bossklein ULTRAbio</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOS9770</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:39:47.992Z</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>2026-06-19T13:26:03.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060493854608</udiDi>
    <basicUdiDi>1506049385Oil8N</basicUdiDi>
    <tradeName>Unodent Unolube Universal Handpiece Oil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GOU100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:10:11.649Z</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>
</eudamedExport>