<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06973661910022</udiDi>
    <basicUdiDi>B-06973661910022</basicUdiDi>
    <tradeName>SKL</tradeName>
    <deviceName>Ultrasonic scaler</deviceName>
    <manufacturerName>Guangdong SKL Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040821</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K7</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:31:32.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973661910015</udiDi>
    <basicUdiDi>B-06973661910015</basicUdiDi>
    <tradeName>SKL</tradeName>
    <deviceName>Ultrasonic scaler</deviceName>
    <manufacturerName>Guangdong SKL Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040821</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:31:29.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597782482</udiDi>
    <basicUdiDi>B-06972597782482</basicUdiDi>
    <tradeName>Skalea Lux Pro</tradeName>
    <deviceName>Ultrasonic Scaler</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6680080</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:52:02.484Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597781270</udiDi>
    <basicUdiDi>B-06972597781270</basicUdiDi>
    <tradeName>Z-Activator</tradeName>
    <deviceName>Ultrasonic Endo Activation Device</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6280018</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:51:46.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597781218</udiDi>
    <basicUdiDi>B-06972597781218</basicUdiDi>
    <tradeName>Endo Cleaner</tradeName>
    <deviceName>Ultrasonic Endo Activation Device</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6280010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:51:44.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597780112</udiDi>
    <basicUdiDi>B-06972597780112</basicUdiDi>
    <tradeName>UltraMint Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6680001</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:51:26.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597780105</udiDi>
    <basicUdiDi>B-06972597780105</basicUdiDi>
    <tradeName>UltraMint</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6680011</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:51:24.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>06972597780068</udiDi>
    <basicUdiDi>B-06972597780068</basicUdiDi>
    <tradeName>Ultra X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6280001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:51:20.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064788</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Tartar scaler, fig. 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-02</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064795</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Fogkő kaparó, fig. 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-03</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064801</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Fogkő kaparó</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-06</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064818</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Willinger fogkő kaparó</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-32</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064825</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Darby-Perry fogkő kaparó, jobbos</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-33</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064832</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Darby-Perry's scaler, left</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-34</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064849</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Darby-Perry fogkő kaparó, fig. 33 1/2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-35</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:13.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064856</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Darby-Perry fogkő kaparó, fig. 34 1/2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-125-36</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:12.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064863</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Abott fogkő kaparó, enyhe hajlású, 150 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-127-01</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:12.957Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064870</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Abott fogkő kaparó, erős hajlású, 150 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-127-02</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:12.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064887</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Seidel fogkő kaparó, 150 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-129-01</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:12.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>05996660064894</udiDi>
    <basicUdiDi>5996660Fog.tom_kap_szon6S</basicUdiDi>
    <tradeName>Black's tartar scaper, 150 mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság</manufacturerName>
    <manufacturerSrn>HU-MF-000006381</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159009</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY SCALERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD-129-02</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:48:12.881Z</lastUpdated>
  </row>
</eudamedExport>