<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04571215134591</udiDi>
    <basicUdiDi>B-04571215134591</basicUdiDi>
    <tradeName>CERABIEN MiLai E1 (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>109-2121EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134607</udiDi>
    <basicUdiDi>B-04571215134607</basicUdiDi>
    <tradeName>CERABIEN MiLai Silky 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>109-2131EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134614</udiDi>
    <basicUdiDi>B-04571215134614</basicUdiDi>
    <tradeName>CERABIEN MiLai CCV-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>109-2141EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134621</udiDi>
    <basicUdiDi>B-04571215134621</basicUdiDi>
    <tradeName>CERABIEN MiLai CCV-3 (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>109-2151EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134638</udiDi>
    <basicUdiDi>B-04571215134638</basicUdiDi>
    <tradeName>CERABIEN MiLai Fluoro Mamelon 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>109-2161EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134645</udiDi>
    <basicUdiDi>B-04571215134645</basicUdiDi>
    <tradeName>CERABIEN MiLai Fluoro Mamelon 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>109-2171EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134652</udiDi>
    <basicUdiDi>B-04571215134652</basicUdiDi>
    <tradeName>CERABIEN MiLai LT0 (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>109-2181EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134669</udiDi>
    <basicUdiDi>B-04571215134669</basicUdiDi>
    <tradeName>CERABIEN MiLai ELT2 (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>109-2191EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134676</udiDi>
    <basicUdiDi>B-04571215134676</basicUdiDi>
    <tradeName>CERABIEN MiLai LT Coral (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>109-2201EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134683</udiDi>
    <basicUdiDi>B-04571215134683</basicUdiDi>
    <tradeName>CERABIEN MiLai OBXW (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>109-2212EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134690</udiDi>
    <basicUdiDi>B-04571215134690</basicUdiDi>
    <tradeName>CERABIEN MiLai OBA1 (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>109-2222EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134706</udiDi>
    <basicUdiDi>B-04571215134706</basicUdiDi>
    <tradeName>CERABIEN MiLai OBA3 (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>109-2232EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134713</udiDi>
    <basicUdiDi>B-04571215134713</basicUdiDi>
    <tradeName>CERABIEN MiLai OBB1 (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>109-2242EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.327Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134720</udiDi>
    <basicUdiDi>B-04571215134720</basicUdiDi>
    <tradeName>CERABIEN MiLai XWB (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>109-2252EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134737</udiDi>
    <basicUdiDi>B-04571215134737</basicUdiDi>
    <tradeName>CERABIEN MiLai A1B (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>109-2262EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134744</udiDi>
    <basicUdiDi>B-04571215134744</basicUdiDi>
    <tradeName>CERABIEN MiLai A3B (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>109-2272EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134751</udiDi>
    <basicUdiDi>B-04571215134751</basicUdiDi>
    <tradeName>CERABIEN MiLai B1B (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>109-2282EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134768</udiDi>
    <basicUdiDi>B-04571215134768</basicUdiDi>
    <tradeName>CERABIEN MiLai B3B (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>109-2292EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134775</udiDi>
    <basicUdiDi>B-04571215134775</basicUdiDi>
    <tradeName>CERABIEN MiLai C2B (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>109-2302EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134782</udiDi>
    <basicUdiDi>B-04571215134782</basicUdiDi>
    <tradeName>CERABIEN MiLai D2B (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>109-2312EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.186Z</lastUpdated>
  </row>
</eudamedExport>