<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800019140818</udiDi>
    <basicUdiDi>88000191DGRV2</basicUdiDi>
    <tradeName>Digit R</tradeName>
    <deviceName>Digit R</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0380</emdnCode>
    <emdnDescription>DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:31.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019140801</udiDi>
    <basicUdiDi>8800019140801WY</basicUdiDi>
    <tradeName>B&amp;L  GP Gauge&amp;Cutter</tradeName>
    <deviceName>B&amp;L GP Gauge&amp;Cutter</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0380</emdnCode>
    <emdnDescription>DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GGAC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:31.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019140085</udiDi>
    <basicUdiDi>88000191ENDOLF</basicUdiDi>
    <tradeName>Endo R</tradeName>
    <deviceName>Endo M, Endo R, Endo M&amp;R</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0380</emdnCode>
    <emdnDescription>DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:30.336Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019116059</udiDi>
    <basicUdiDi>88000191BLITEGE</basicUdiDi>
    <tradeName>B&amp;Lite S</tradeName>
    <deviceName>B&amp;Lite S</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:26.340Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019115014</udiDi>
    <basicUdiDi>88000191JINSTL5</basicUdiDi>
    <tradeName>JETIP Instruments</tradeName>
    <deviceName>JETIP Instruments</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:25.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019110910</udiDi>
    <basicUdiDi>88000191LEETRACK4</basicUdiDi>
    <tradeName>Leetrac</tradeName>
    <deviceName>LEETRAC</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L150201</emdnCode>
    <emdnDescription>DENTAL RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Leetrac</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:24.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019110422</udiDi>
    <basicUdiDi>88000191ISTIPMQ</basicUdiDi>
    <tradeName>IS TIP</tradeName>
    <deviceName>IS TIP</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:23.936Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019110309</udiDi>
    <basicUdiDi>88000191JETIPJZ</basicUdiDi>
    <tradeName>JETIP</tradeName>
    <deviceName>JETIP</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:19.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019110262</udiDi>
    <basicUdiDi>88000191BLTIPHS</basicUdiDi>
    <tradeName>BL TIP</tradeName>
    <deviceName>BL TIP</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>Q010199</emdnCode>
    <emdnDescription>CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:19.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019110101</udiDi>
    <basicUdiDi>88000191BKONLA</basicUdiDi>
    <tradeName>BL-B Kondenser</tradeName>
    <deviceName>BL-B Kondenser</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:18.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019110002</udiDi>
    <basicUdiDi>88000191SKONPZ</basicUdiDi>
    <tradeName>BL-S Kondenser</tradeName>
    <deviceName>BL-S Kondenser</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:17.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019101628</udiDi>
    <basicUdiDi>88000191BETAJZ</basicUdiDi>
    <tradeName>SuperEndo-Beta</tradeName>
    <deviceName>SuperEndo-Beta</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>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:13.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019101505</udiDi>
    <basicUdiDi>88000191MINIMY</basicUdiDi>
    <tradeName>BSN2420</tradeName>
    <deviceName>Beta Mini</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>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:12.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100003</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>SuperEndo-Alpha II</tradeName>
    <deviceName>SuperEndo-Alpha II</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>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:17:11.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100010</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>SuperEndo-Alpha II</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>2026-06-25T11:31:24.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100188</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>BP5508L</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>BP5508L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:31:24.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100249</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>SPRDN</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>SPRDN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:31:24.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019100256</udiDi>
    <basicUdiDi>88000191ALPHAFS</basicUdiDi>
    <tradeName>SPRDS</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>SPRDS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:31:24.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019101581</udiDi>
    <basicUdiDi>88000191MINIMY</basicUdiDi>
    <tradeName>BSN5020</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>BSN5020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T11:31:24.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800019101635</udiDi>
    <basicUdiDi>88000191BETAJZ</basicUdiDi>
    <tradeName>SuperEndo-Beta</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>2026-06-25T11:31:24.047Z</lastUpdated>
  </row>
</eudamedExport>