<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10810000524003</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S435</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524010</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S453S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.453Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524027</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S454S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524034</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S456S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524041</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S460S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524058</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S461S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524065</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S463S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524133</udiDi>
    <basicUdiDi>081000052IMPRESSIONL3</basicUdiDi>
    <tradeName>Mach-2</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S433S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524157</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S437S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524171</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S438S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524188</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S440S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.267Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524195</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S448S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524201</udiDi>
    <basicUdiDi>081000052IMPRESSIONL3</basicUdiDi>
    <tradeName>Green-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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S455S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>10810000524225</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>MDR 2017/745</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S457S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:32.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040143889</udiDi>
    <basicUdiDi>B-00304040143889</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Bite Registrations</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002623</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:12:14.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040143872</udiDi>
    <basicUdiDi>B-00304040143872</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>Bite Registrations</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001268</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:12:11.766Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040143865</udiDi>
    <basicUdiDi>B-00304040143865</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>VPS (A-Silicones)</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002134</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:12:10.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040143858</udiDi>
    <basicUdiDi>B-00304040143858</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>VPS (A-Silicones)</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9002133</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:12:09.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040143841</udiDi>
    <basicUdiDi>B-00304040143841</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>VPS (A-Silicones)</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9882045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:12:07.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>00304040143834</udiDi>
    <basicUdiDi>B-00304040143834</basicUdiDi>
    <tradeName>Henry Schein</tradeName>
    <deviceName>C-Silicones</deviceName>
    <manufacturerName>Henry Schein Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000021683</manufacturerSrn>
    <authorisedRepresentativeName>Henry Schein Services GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01020102</emdnCode>
    <emdnDescription>DENTAL IMPRESSION VINYLSILOXANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9882044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:12:05.368Z</lastUpdated>
  </row>
</eudamedExport>