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<eudamedExport entity="devices">
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    <basicUdiDi>B-07640142413554</basicUdiDi>
    <tradeName>BT-Apisafe</tradeName>
    <deviceName>BT-Apisafe</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.6B0.00.0AD.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:52.631Z</lastUpdated>
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  <row>
    <udiDi>07640142413516</udiDi>
    <basicUdiDi>B-07640142413516</basicUdiDi>
    <tradeName>BT-Apisafe</tradeName>
    <deviceName>BT-Apisafe</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.6B0.00.0AA.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:38.840Z</lastUpdated>
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  <row>
    <udiDi>07640142413318</udiDi>
    <basicUdiDi>B-07640142413318</basicUdiDi>
    <tradeName>PRERACE</tradeName>
    <deviceName>PRERACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.7B0.00.0DB.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:34.834Z</lastUpdated>
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  <row>
    <udiDi>07640142413264</udiDi>
    <basicUdiDi>B-07640142413264</basicUdiDi>
    <tradeName>PRERACE</tradeName>
    <deviceName>PRERACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.7B0.00.0DC.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:34.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142411871</udiDi>
    <basicUdiDi>B-07640142411871</basicUdiDi>
    <tradeName>PRERACE</tradeName>
    <deviceName>PRERACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.0DB.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:20.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142411659</udiDi>
    <basicUdiDi>B-07640142411659</basicUdiDi>
    <tradeName>PRERACE</tradeName>
    <deviceName>PRERACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.0DC.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:19.624Z</lastUpdated>
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  <row>
    <udiDi>07640142411123</udiDi>
    <basicUdiDi>B-07640142411123</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.7B0.00.SAE.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:14.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142411116</udiDi>
    <basicUdiDi>B-07640142411116</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1.7B0.00.SAB.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:14.027Z</lastUpdated>
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  <row>
    <udiDi>07640142411048</udiDi>
    <basicUdiDi>B-07640142411048</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAF.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:13.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142411031</udiDi>
    <basicUdiDi>B-07640142411031</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAE.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:09.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142411024</udiDi>
    <basicUdiDi>B-07640142411024</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAD.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:08.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142411017</udiDi>
    <basicUdiDi>B-07640142411017</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAC.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:07.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142410027</udiDi>
    <basicUdiDi>B-07640142410027</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAB.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:06.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640142410010</udiDi>
    <basicUdiDi>B-07640142410010</basicUdiDi>
    <tradeName>IRACE</tradeName>
    <deviceName>IRACE</deviceName>
    <manufacturerName>FKG Dentaire Sàrl</manufacturerName>
    <manufacturerSrn>CH-MF-000017925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.7B0.00.SAA.FK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:50:02.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>04546951605933</udiDi>
    <basicUdiDi>B-04546951605933</basicUdiDi>
    <tradeName>JIZAI - 025 14 31mm</tradeName>
    <deviceName>MANI NiTi FILES</deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:57:25.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835156898</udiDi>
    <basicUdiDi>69448351ENDO01NS2X</basicUdiDi>
    <tradeName>Root Canal Files</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA1010401A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:38:10.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835156904</udiDi>
    <basicUdiDi>69448351ENDO01NS2X</basicUdiDi>
    <tradeName>Root Canal Files</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA1010402A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:38:10.711Z</lastUpdated>
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  <row>
    <udiDi>06944835156911</udiDi>
    <basicUdiDi>69448351ENDO01NS2X</basicUdiDi>
    <tradeName>Root Canal Files</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA1010403A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:38:10.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835156928</udiDi>
    <basicUdiDi>69448351ENDO01NS2X</basicUdiDi>
    <tradeName>Root Canal Files</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA1010404A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:38:10.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944835156935</udiDi>
    <basicUdiDi>69448351ENDO01NS2X</basicUdiDi>
    <tradeName>Root Canal Files</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000027059</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159004</emdnCode>
    <emdnDescription>ENDODONTIC RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BA1010405A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:38:10.656Z</lastUpdated>
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</eudamedExport>