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<eudamedExport entity="devices">
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    <udiDi>04713909450437</udiDi>
    <basicUdiDi>471390945CLQ6E5</basicUdiDi>
    <tradeName>Dental Curing Light</tradeName>
    <deviceName>ELiTEDENT</deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:35.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450413</udiDi>
    <basicUdiDi>471390945CLQ4DZ</basicUdiDi>
    <tradeName>Dental Curing Light</tradeName>
    <deviceName>ELiTEDENT</deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:34.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450390</udiDi>
    <basicUdiDi>471390945ULTRALITE5P</basicUdiDi>
    <tradeName>Dental Curing Light 1000E</tradeName>
    <deviceName>ULTRA-LITE</deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:34.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450406</udiDi>
    <basicUdiDi>471390945ULTRALITE5P</basicUdiDi>
    <tradeName>Dental Curing Light 1800E</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1119</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450512</udiDi>
    <basicUdiDi>B-04713909450512</basicUdiDi>
    <tradeName>Ultrasonic Scaler MS-10</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1210</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450529</udiDi>
    <basicUdiDi>B-04713909450529</basicUdiDi>
    <tradeName>Ultrasonic Scaler MS-10B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1211</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450536</udiDi>
    <basicUdiDi>B-04713909450536</basicUdiDi>
    <tradeName>Ultrasonic Scaler PS-25</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450543</udiDi>
    <basicUdiDi>B-04713909450543</basicUdiDi>
    <tradeName>Ultrasonic Scaler MS-30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1218</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450550</udiDi>
    <basicUdiDi>B-04713909450550</basicUdiDi>
    <tradeName>Ultrasonic Scaler MS-1/MS-1 Dual</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1214</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450567</udiDi>
    <basicUdiDi>B-04713909450567</basicUdiDi>
    <tradeName>Ultrasonic Scaler PS-1/PS-1 Dual</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1204, 1207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450574</udiDi>
    <basicUdiDi>B-04713909450574</basicUdiDi>
    <tradeName>Ultrasonic Scaler PS-30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1209</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450581</udiDi>
    <basicUdiDi>B-04713909450581</basicUdiDi>
    <tradeName>Ultrasonic Scaler PS-25B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1202</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450598</udiDi>
    <basicUdiDi>B-04713909450598</basicUdiDi>
    <tradeName>Ultrasonic Scaler MS-50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ULTRASONIC CLEANING EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1232</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450628</udiDi>
    <basicUdiDi>B-04713909450628</basicUdiDi>
    <tradeName>Protable X-Ray XR-01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450635</udiDi>
    <basicUdiDi>B-04713909450635</basicUdiDi>
    <tradeName>Sensor RXS 1000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450642</udiDi>
    <basicUdiDi>471390945CLQ6E5</basicUdiDi>
    <tradeName>Dental Curing Light Q6-NLG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1133</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:04:28.157Z</lastUpdated>
  </row>
</eudamedExport>