<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07798148623122</udiDi>
    <basicUdiDi>779814862PLUSX4</basicUdiDi>
    <tradeName>PLUS PL3 25x70 – PL16</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLUS PL3 25x70 – PL16</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623139</udiDi>
    <basicUdiDi>779814862PLUSX4</basicUdiDi>
    <tradeName>PLUS PL3 25x90 – PL17</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PLUS PL3 25x90 – PL17</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623450</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 22 GRANDE EL1 – BF42</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 22 GRANDE EL1 – BF42</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623467</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 22 PEQUEÑO EL2 – BF45</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 22 PEQUEÑO EL2 – BF45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623474</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 22 GRANDE EL2 – BF46</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 22 GRANDE EL2 – BF46</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623481</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 22 PEQUEÑO EL3 – BF47</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 22 PEQUEÑO EL3 – BF47</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623498</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 22 GRANDE EL3 – BF48</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 22 GRANDE EL3 – BF48</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623504</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 25 PEQUEÑO EL1 – BF49</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 25 PEQUEÑO EL1 – BF49</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623511</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 25 GRANDE EL1 – BF50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 25 GRANDE EL1 – BF50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623528</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 25 PEQUEÑO EL2 – BF51</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 25 PEQUEÑO EL2 – BF51</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623535</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 25 GRANDE EL2 – BF52</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 25 GRANDE EL2 – BF52</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623542</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 25 PEQUEÑO EL3 – BF53</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 25 PEQUEÑO EL3 – BF53</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623559</udiDi>
    <basicUdiDi>779814862ELASST</basicUdiDi>
    <tradeName>BULKFLEX ELASTIK 25 GRANDE EL3 – BF54</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BULKFLEX ELASTIK 25 GRANDE EL3 – BF54</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623573</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT1 22x85 – MT01</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT1 22x85 – MT01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623580</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT1 22x120 – MT02</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT1 22x120 – MT02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623597</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT1 25x50 – MT03</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT1 25x50 – MT03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623603</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT1 25x70 – MT04</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT1 25x70 – MT04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623610</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT1 25x90 – MT05</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT1 25x90 – MT05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623627</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT2 22x55 – MT06</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT2 22x55 – MT06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>07798148623634</udiDi>
    <basicUdiDi>779814862MELTUK</basicUdiDi>
    <tradeName>MELTYX MT2 22x85 – MT07</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NUXEN SRL</manufacturerName>
    <manufacturerSrn>AR-MF-000029448</manufacturerSrn>
    <authorisedRepresentativeName>Cinterqual-Soluções de Comércio Internacional,Lda.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000002813</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MELTYX MT2 22x85 – MT07</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:47:00.243Z</lastUpdated>
  </row>
</eudamedExport>