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<eudamedExport entity="devices">
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    <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>2026-07-04T15:32:51.845Z</lastUpdated>
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  <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>2026-07-04T15:32:51.049Z</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>2026-07-04T15:32:49.445Z</lastUpdated>
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  <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>2026-07-04T15:32:47.045Z</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>2026-07-04T15:32:45.442Z</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>2026-07-04T15:32:44.641Z</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>2026-07-04T15:32:43.048Z</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>2026-07-04T15:32:40.643Z</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>2026-07-04T15:32:39.039Z</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>2026-07-04T15:32:38.241Z</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>2026-07-04T15:32:36.738Z</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>2026-07-04T15:32:22.962Z</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>2026-07-04T15:32:18.962Z</lastUpdated>
  </row>
  <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>2026-07-04T15:32:18.176Z</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>2026-07-01T22:59:47.689Z</lastUpdated>
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  <row>
    <udiDi>05060493850105</udiDi>
    <basicUdiDi>1506049385Oil8N</basicUdiDi>
    <tradeName>polydent Universal Handpiece Oil Spray</tradeName>
    <deviceName>Universal Handpiece Oil</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>MDR 2017/745</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1899-001</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:23:54.419Z</lastUpdated>
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    <udiDi>+E165600210610</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Coltene Bioscience UC40</tradeName>
    <deviceName>Ultrasonic Cleaner</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>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60021961</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:22:18.382Z</lastUpdated>
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    <udiDi>+E165600210600</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Coltene Biosonic UC40</tradeName>
    <deviceName>Ultrasonic Cleaner</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>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60021960</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:56:33.541Z</lastUpdated>
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    <udiDi>10810000526847</udiDi>
    <basicUdiDi>081000052MIXINGTIP2JX</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S275</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:36.824Z</lastUpdated>
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    <udiDi>10810000526960</udiDi>
    <basicUdiDi>081000052NEEDLETIP4ZK</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></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S383</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:36.154Z</lastUpdated>
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