<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04571215134515</udiDi>
    <basicUdiDi>B-04571215134515</basicUdiDi>
    <tradeName>CERABIEN MiLai OBB1 (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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-2041EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:48.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134492</udiDi>
    <basicUdiDi>B-04571215134492</basicUdiDi>
    <tradeName>CERABIEN MiLai OBA1 (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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-2021EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:46.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134485</udiDi>
    <basicUdiDi>B-04571215134485</basicUdiDi>
    <tradeName>CERABIEN MiLai OBXW (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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-2011EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:45.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134041</udiDi>
    <basicUdiDi>B-04571215134041</basicUdiDi>
    <tradeName>CERABIEN MiLai INTERNAL STAIN 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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0020EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:41.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134034</udiDi>
    <basicUdiDi>B-04571215134034</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Fluoro (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0511EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:40.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134027</udiDi>
    <basicUdiDi>B-04571215134027</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Bright (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0501EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:39.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134010</udiDi>
    <basicUdiDi>B-04571215134010</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain B+ (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0491EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:39.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215134003</udiDi>
    <basicUdiDi>B-04571215134003</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain A+ (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0481EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:35.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133990</udiDi>
    <basicUdiDi>B-04571215133990</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Tissue Red (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0471EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:34.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133983</udiDi>
    <basicUdiDi>B-04571215133983</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Tissue Pink (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0461EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:33.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133976</udiDi>
    <basicUdiDi>B-04571215133976</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Salmon Pink (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0451EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:32.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133952</udiDi>
    <basicUdiDi>B-04571215133952</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Mamelon Orange 2 (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0431EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:28.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133945</udiDi>
    <basicUdiDi>B-04571215133945</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Yellow (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0421EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:27.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133938</udiDi>
    <basicUdiDi>B-04571215133938</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Blue (3g)</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>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0411EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:14.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133921</udiDi>
    <basicUdiDi>B-04571215133921</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Incisal Blue 2 (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0401EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:12.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133914</udiDi>
    <basicUdiDi>B-04571215133914</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Incisal Blue 1 (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0391EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:10.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133907</udiDi>
    <basicUdiDi>B-04571215133907</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain Gray (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0381EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:10.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133891</udiDi>
    <basicUdiDi>B-04571215133891</basicUdiDi>
    <tradeName>CERABIEN MiLai Internal Stain White (3g)</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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0371EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:08.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133884</udiDi>
    <basicUdiDi>B-04571215133884</basicUdiDi>
    <tradeName>CERABIEN MiLai MICRO 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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0010EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:06.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04571215133877</udiDi>
    <basicUdiDi>B-04571215133877</basicUdiDi>
    <tradeName>CERABIEN MiLai Value Liner 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>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109-0362EU</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:52:04.588Z</lastUpdated>
  </row>
</eudamedExport>