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<eudamedExport entity="devices">
  <row>
    <udiDi>06936340086180</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 040</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:09.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086173</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 035</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:08.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086166</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 035</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:07.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086159</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:06.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086142</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:05.075Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086135</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:03.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086128</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 025</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:02.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086111</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:01.474Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086104</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 020</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:14:00.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086098</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:13:59.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086081</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-K  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS 2102 015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:13:57.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086050</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-OP  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP 2104 015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:59.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086043</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-OP  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP 2104 015</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:58.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086036</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-OP  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP 2106 010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:57.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086029</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-OP  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP 2106 010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:55.989Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086012</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-OP  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP 2104 010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:54.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340086005</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Micro-Shaper-OP  Shaper</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP 2104 010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:12:53.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340023017</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Barbed broach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB 2800 060</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:06:18.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340023000</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Barbed broach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB 2800 060</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:06:17.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340022997</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>Barbed broach</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shandong Hengfeng Kerui Medical Equipment Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000042567</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB 2800 050</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:06:16.085Z</lastUpdated>
  </row>
</eudamedExport>