<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04571215133563</udiDi>
    <basicUdiDi>B-04571215133563</basicUdiDi>
    <tradeName>CERABIEN MiLai Tx (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0051EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133570</udiDi>
    <basicUdiDi>B-04571215133570</basicUdiDi>
    <tradeName>CERABIEN MiLai ELT1 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0061EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133587</udiDi>
    <basicUdiDi>B-04571215133587</basicUdiDi>
    <tradeName>CERABIEN MiLai LTx (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0071EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133594</udiDi>
    <basicUdiDi>B-04571215133594</basicUdiDi>
    <tradeName>CERABIEN MiLai LT1 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0081EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133600</udiDi>
    <basicUdiDi>B-04571215133600</basicUdiDi>
    <tradeName>CERABIEN MiLai LT Super Gray (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0091EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133617</udiDi>
    <basicUdiDi>B-04571215133617</basicUdiDi>
    <tradeName>CERABIEN MiLai LT Royal Blue (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0101EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.724Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133624</udiDi>
    <basicUdiDi>B-04571215133624</basicUdiDi>
    <tradeName>CERABIEN MiLai Aqua Blue 2 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0111EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133631</udiDi>
    <basicUdiDi>B-04571215133631</basicUdiDi>
    <tradeName>CERABIEN MiLai Creamy Enamel (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0121EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133648</udiDi>
    <basicUdiDi>B-04571215133648</basicUdiDi>
    <tradeName>CERABIEN MiLai E2 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0131EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133655</udiDi>
    <basicUdiDi>B-04571215133655</basicUdiDi>
    <tradeName>CERABIEN MiLai CCV-2 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0141EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133662</udiDi>
    <basicUdiDi>B-04571215133662</basicUdiDi>
    <tradeName>CERABIEN MiLai Tissue 1 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0151EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.608Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133679</udiDi>
    <basicUdiDi>B-04571215133679</basicUdiDi>
    <tradeName>CERABIEN MiLai Tissue 4 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0161EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133686</udiDi>
    <basicUdiDi>B-04571215133686</basicUdiDi>
    <tradeName>CERABIEN MiLai Tissue 5 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0171EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133693</udiDi>
    <basicUdiDi>B-04571215133693</basicUdiDi>
    <tradeName>CERABIEN MiLai Tissue 6 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0181EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133709</udiDi>
    <basicUdiDi>B-04571215133709</basicUdiDi>
    <tradeName>CERABIEN MiLai Value Liner 1 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0191EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133716</udiDi>
    <basicUdiDi>B-04571215133716</basicUdiDi>
    <tradeName>CERABIEN MiLai Value Liner 2 (10g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0201EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133723</udiDi>
    <basicUdiDi>B-04571215133723</basicUdiDi>
    <tradeName>CERABIEN MiLai Tx (50g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0212EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133730</udiDi>
    <basicUdiDi>B-04571215133730</basicUdiDi>
    <tradeName>CERABIEN MiLai ELT1 (50g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0222EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133747</udiDi>
    <basicUdiDi>B-04571215133747</basicUdiDi>
    <tradeName>CERABIEN MiLai LTx (50g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0232EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133754</udiDi>
    <basicUdiDi>B-04571215133754</basicUdiDi>
    <tradeName>CERABIEN MiLai LT1 (50g)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Kuraray Noritake Dental Inc. Miyoshi</manufacturerName>
    <manufacturerSrn>JP-MF-000017328</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0242EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:26.445Z</lastUpdated>
  </row>
</eudamedExport>