<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07640397422226</udiDi>
    <basicUdiDi>764018507STATIM5000S3S</basicUdiDi>
    <tradeName>STATIM 5000S Cassette Autoclave</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent4You AG</manufacturerName>
    <manufacturerSrn>CH-MF-000028926</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011305</emdnCode>
    <emdnDescription>SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>01-222313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:48:49.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640397422233</udiDi>
    <basicUdiDi>764018507STATIM5000S3S</basicUdiDi>
    <tradeName>STATIM 5000S Cassette Autoclave</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent4You AG</manufacturerName>
    <manufacturerSrn>CH-MF-000028926</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011305</emdnCode>
    <emdnDescription>SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>01-232313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:48:49.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640397422240</udiDi>
    <basicUdiDi>764018507STATIM2000G4SV</basicUdiDi>
    <tradeName>STATIM 2000 G4 Cassette Autoclave</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent4You AG</manufacturerName>
    <manufacturerSrn>CH-MF-000028926</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011305</emdnCode>
    <emdnDescription>SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G4-152314</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:48:49.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640397422257</udiDi>
    <basicUdiDi>764018507STATIM5000G4U4</basicUdiDi>
    <tradeName>STATIM 5000 G4 Cassette Autoclave</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent4You AG</manufacturerName>
    <manufacturerSrn>CH-MF-000028926</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011305</emdnCode>
    <emdnDescription>SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G4-222313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:48:49.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640397422264</udiDi>
    <basicUdiDi>764018507STATIM5000G4U4</basicUdiDi>
    <tradeName>STATIM 5000 G4 Cassette Autoclave</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dent4You AG</manufacturerName>
    <manufacturerSrn>CH-MF-000028926</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12011305</emdnCode>
    <emdnDescription>SMALL LOAD AUTOCLAVES WITH A CHAMBER SMALLER THAN 1 STANDARD STERILISATION UNIT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>G4-232313</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:48:49.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139410</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 LED USA Plug Type A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60013941</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139420</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 LED EURO Plug Type C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013942</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139430</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 LED UK Plug Type G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013943</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139440</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 LED Australia Plug Type IA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60013944</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139450</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 LED Japan Plug Type AJ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60013945</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.407Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139460</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 LED Chinese Plug Type CH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>60013946</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139481</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Light Shield, 8mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013948</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139491</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Barrier Sleeves, 100 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013949</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139500</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Clear Light Guide, 8mm Turbo Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013950</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139510</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Clear Light Guide, 11mm Straight Tip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013951</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139520</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Battery Module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139530</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Charger Base</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013953</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600139550</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Power Supply</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60013955</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600143601</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Light Shield, 11mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60014360</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661600144440</udiDi>
    <basicUdiDi>++D661076L2</basicUdiDi>
    <tradeName>SPEC 3 Eye Shield</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60014444</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:03.179Z</lastUpdated>
  </row>
</eudamedExport>