<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974242197184</udiDi>
    <basicUdiDi>697060203OS0019Z</basicUdiDi>
    <tradeName>06974242197184</tradeName>
    <deviceName>Obturation System</deviceName>
    <manufacturerName>Chengdu Sani Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011715</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:31:16.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974242196217</udiDi>
    <basicUdiDi>697060203DI00142</basicUdiDi>
    <tradeName>06974242196217</tradeName>
    <deviceName>Dental Instruments</deviceName>
    <manufacturerName>Chengdu Sani Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011715</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Composite Instrument</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:31:14.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936340000001</udiDi>
    <basicUdiDi>69363400DRCI001H3</basicUdiDi>
    <tradeName>K FILES</tradeName>
    <deviceName>Dental Root Canal Instruments</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>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSK 2102 006</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:05:37.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003475574</udiDi>
    <basicUdiDi>08964003475IVRT11CW</basicUdiDi>
    <tradeName>Ivory Retainer</tradeName>
    <deviceName>Ivory Retainer</deviceName>
    <manufacturerName>JAZBAR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000031447</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>irt11g</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:10:31.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003475543</udiDi>
    <basicUdiDi>08964003475FLCP144J</basicUdiDi>
    <tradeName>Filling Instrument Composite</tradeName>
    <deviceName>Filling Instrument Composite</deviceName>
    <manufacturerName>JAZBAR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000031447</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>fc35</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:10:27.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003475536</udiDi>
    <basicUdiDi>08964003475FLRH136H</basicUdiDi>
    <tradeName>Filling instrument Round heads</tradeName>
    <deviceName>Filling instrument Round heads</deviceName>
    <manufacturerName>JAZBAR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000031447</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Fr36</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:10:21.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003475376</udiDi>
    <basicUdiDi>08964003475FLAG132M</basicUdiDi>
    <tradeName>Filling Instrument Alugit</tradeName>
    <deviceName>Filling Instrument Alugit</deviceName>
    <manufacturerName>JAZBAR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000031447</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JI-FIA-20</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:09:48.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003475369</udiDi>
    <basicUdiDi>08964003475FLCB1228</basicUdiDi>
    <tradeName>Filling Instrument Cu Bile</tradeName>
    <deviceName>Filling Instrument Cu Bile</deviceName>
    <manufacturerName>JAZBAR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000031447</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JI-FICB-19</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:09:42.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08964003475352</udiDi>
    <basicUdiDi>08964003475FLGI1145</basicUdiDi>
    <tradeName>Filling Instrument</tradeName>
    <deviceName>Filling Instrument</deviceName>
    <manufacturerName>JAZBAR INTERNATIONAL</manufacturerName>
    <manufacturerSrn>PK-MF-000031447</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JI-FI-16</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:09:41.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970873260143</udiDi>
    <basicUdiDi>6970873260143B3</basicUdiDi>
    <tradeName>Gutta percha obturation system</tradeName>
    <deviceName>Gutta percha obturation system</deviceName>
    <manufacturerName>DENJOY DENTAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000044157</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DY-GP  Plus</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:31:51.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970602031846</udiDi>
    <basicUdiDi>697060203RCF0016T</basicUdiDi>
    <tradeName>06970602031846</tradeName>
    <deviceName>Root Canal File</deviceName>
    <manufacturerName>Chengdu Sani Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011715</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T04:06:00.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942200999095</udiDi>
    <basicUdiDi>69422009GPCUTTER7Q</basicUdiDi>
    <tradeName>GP Flow</tradeName>
    <deviceName>Gutta Percha Cutting Pen</deviceName>
    <manufacturerName>Shanwei Perfect Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000033003</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP Flow</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:30:30.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941877812713</udiDi>
    <basicUdiDi>B-06941877812713</basicUdiDi>
    <tradeName>Space-Fill</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>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6380401</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:52:36.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941877812690</udiDi>
    <basicUdiDi>B-06941877812690</basicUdiDi>
    <tradeName>Space-Pack</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>UNKNOWN</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6380301</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-25T15:52:34.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100140</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP3004</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;L Biotech</manufacturerName>
    <manufacturerSrn>KR-MF-000023296</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:34:28.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100157</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP3504</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;L Biotech</manufacturerName>
    <manufacturerSrn>KR-MF-000023296</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:34:28.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100164</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP4004</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;L Biotech</manufacturerName>
    <manufacturerSrn>KR-MF-000023296</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:34:28.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100171</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP4504</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;L Biotech</manufacturerName>
    <manufacturerSrn>KR-MF-000023296</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:34:28.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100195</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP5004</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;L Biotech</manufacturerName>
    <manufacturerSrn>KR-MF-000023296</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:34:28.555Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100201</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP5506</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;L Biotech</manufacturerName>
    <manufacturerSrn>KR-MF-000023296</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010299</emdnCode>
    <emdnDescription>ROOT CANAL FILLING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:34:28.536Z</lastUpdated>
  </row>
</eudamedExport>