<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04571215134799</udiDi>
    <basicUdiDi>B-04571215134799</basicUdiDi>
    <tradeName>CERABIEN MiLai E1 (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>109-2322EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134805</udiDi>
    <basicUdiDi>B-04571215134805</basicUdiDi>
    <tradeName>CERABIEN MiLai Silky E2 (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>109-2332EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134812</udiDi>
    <basicUdiDi>B-04571215134812</basicUdiDi>
    <tradeName>CERABIEN MiLai CCV-1 (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>109-2342EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134829</udiDi>
    <basicUdiDi>B-04571215134829</basicUdiDi>
    <tradeName>CERABIEN MiLai CCV-3 (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>109-2352EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134836</udiDi>
    <basicUdiDi>B-04571215134836</basicUdiDi>
    <tradeName>CERABIEN MiLai Fluoro Mamelon 1 (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>109-2362EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134843</udiDi>
    <basicUdiDi>B-04571215134843</basicUdiDi>
    <tradeName>CERABIEN MiLai Fluoro Mamelon 2 (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></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-2372EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134850</udiDi>
    <basicUdiDi>B-04571215134850</basicUdiDi>
    <tradeName>CERABIEN MiLai LT0 (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>109-2382EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134867</udiDi>
    <basicUdiDi>B-04571215134867</basicUdiDi>
    <tradeName>CERABIEN MiLai ELT2 (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>109-2392EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134874</udiDi>
    <basicUdiDi>B-04571215134874</basicUdiDi>
    <tradeName>CERABIEN MiLai LT Coral (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>109-2402EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:06.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134881</udiDi>
    <basicUdiDi>B-04571215134881</basicUdiDi>
    <tradeName>CERABIEN MiLai ADVANCED LAYERING KIT</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>109-2412EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:05.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134898</udiDi>
    <basicUdiDi>B-04571215134898</basicUdiDi>
    <tradeName>CERABIEN MiLai POWDER STARTER KIT</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>109-2422EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:05.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215181670</udiDi>
    <basicUdiDi>B-04571215181670</basicUdiDi>
    <tradeName>IS LIQUID (10ml)</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>126-0111EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:05.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215181687</udiDi>
    <basicUdiDi>B-04571215181687</basicUdiDi>
    <tradeName>IS LIQUID (100ml)</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>126-0122EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:05.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215181700</udiDi>
    <basicUdiDi>B-04571215181700</basicUdiDi>
    <tradeName>LF LIQUID (100ml)</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>126-0232EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:55:05.901Z</lastUpdated>
  </row>
</eudamedExport>