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<eudamedExport entity="devices">
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    <udiDi>08714729858706</udiDi>
    <basicUdiDi>01915060000000000000576NS</basicUdiDi>
    <tradeName>TRUEtome™</tradeName>
    <deviceName>TRUEtome Hydra Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00583160</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:09:27.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729172017</udiDi>
    <basicUdiDi>01915060000000000000522N3</basicUdiDi>
    <tradeName>MicroKnife™</tradeName>
    <deviceName>Triple Lumen Needle Knife</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00532810</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:11.502Z</lastUpdated>
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  <row>
    <udiDi>08714729103257</udiDi>
    <basicUdiDi>01915060000000000000523N5</basicUdiDi>
    <tradeName>Ultratome™</tradeName>
    <deviceName>Ultratome XL Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00535900</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:06.866Z</lastUpdated>
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  <row>
    <udiDi>00191506039240</udiDi>
    <basicUdiDi>01915060000000000000521MZ</basicUdiDi>
    <tradeName>Dreamtome™</tradeName>
    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00584400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:37.318Z</lastUpdated>
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  <row>
    <udiDi>00191506039226</udiDi>
    <basicUdiDi>01915060000000000000520MX</basicUdiDi>
    <tradeName>Autotome™</tradeName>
    <deviceName>Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00584380</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:36.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729953272</udiDi>
    <basicUdiDi>01915060000000000000263N2</basicUdiDi>
    <tradeName>TRUEtome™</tradeName>
    <deviceName>TRUEtome Revolution Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00583260</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:59:02.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729827610</udiDi>
    <basicUdiDi>01915060000000000000262MY</basicUdiDi>
    <tradeName>TRUEtome™ 49</tradeName>
    <deviceName>TRUEtome Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00584150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:14.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002225367</udiDi>
    <basicUdiDi>0827002WCM00000000012MF</basicUdiDi>
    <tradeName>Cannulatome II® PC Double Lumen Sphincterotome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-20M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:11.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729268642</udiDi>
    <basicUdiDi>01915060000000000000369NK</basicUdiDi>
    <tradeName>RX ERCP</tradeName>
    <deviceName>ERCP (Endoscopic Retrograde Cholangiopancreatography) Cannula</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010101</emdnCode>
    <emdnDescription>ERCP CANNULAS, SINGLE-LUMEN, STANDARD TIP</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00545760</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:57:05.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>M294CM1791260</udiDi>
    <basicUdiDi>++M294CM179126KX</basicUdiDi>
    <tradeName>Cannula lumen flexible pick; Ø1.5mmx25cm</tradeName>
    <deviceName>Cannula lumen flexible pick; Ø1.5mmx25cm</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010299</emdnCode>
    <emdnDescription>ERCP CANNULAS, MULTI-LUMEN - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM179126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:48:57.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>M294CM1791250</udiDi>
    <basicUdiDi>++M294CM179125KV</basicUdiDi>
    <tradeName>Cannula lumen flexible pick; Ø1.2mmx20cm</tradeName>
    <deviceName>Cannula lumen flexible pick; Ø1.2mmx20cm</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010299</emdnCode>
    <emdnDescription>ERCP CANNULAS, MULTI-LUMEN - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM179125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:48:56.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>M294CM1791240</udiDi>
    <basicUdiDi>++M294CM179124KT</basicUdiDi>
    <tradeName>Cannula lumen flexible pick; Ø0.9mmx20cm</tradeName>
    <deviceName>Cannula lumen flexible pick; Ø0.9mmx20cm</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010299</emdnCode>
    <emdnDescription>ERCP CANNULAS, MULTI-LUMEN - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM179124</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:48:55.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>M294CM1791220</udiDi>
    <basicUdiDi>++M294CM179122KP</basicUdiDi>
    <tradeName>Cannula lumen flexible pick; Ø0.5mmx20cm</tradeName>
    <deviceName>Cannula lumen flexible pick; Ø0.5mmx20cm</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010299</emdnCode>
    <emdnDescription>ERCP CANNULAS, MULTI-LUMEN - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM179122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:48:51.595Z</lastUpdated>
  </row>
  <row>
    <udiDi>M294CM1791210</udiDi>
    <basicUdiDi>++M294CM179121KM</basicUdiDi>
    <tradeName>Cannula lumen flexible pick; Ø0.3mmx20cm</tradeName>
    <deviceName>Cannula lumen flexible pick; Ø0.3mmx20cm</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010299</emdnCode>
    <emdnDescription>ERCP CANNULAS, MULTI-LUMEN - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM179121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:48:50.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>CM179123</udiDi>
    <basicUdiDi>++M294CM179123KR</basicUdiDi>
    <tradeName>Cannula lumen flexible pick; Ø0.7mmx20cm</tradeName>
    <deviceName>Cannula lumen flexible pick; Ø0.7mmx20cm</deviceName>
    <manufacturerName>CLINIMED</manufacturerName>
    <manufacturerSrn>US-MF-000033329</manufacturerSrn>
    <authorisedRepresentativeName>ANTEX MEDI SOLUTION</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000008078</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0304010299</emdnCode>
    <emdnDescription>ERCP CANNULAS, MULTI-LUMEN - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM179123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T18:44:36.275Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002227323</udiDi>
    <basicUdiDi>0827002WCM00000000012MF</basicUdiDi>
    <tradeName>Cotton® CannulaTome®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCPT-25ME</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:23.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002219694</udiDi>
    <basicUdiDi>0827002WCM00000000012MF</basicUdiDi>
    <tradeName>Cotton® CannulaTome®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCPT-25-MONO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:22.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002222403</udiDi>
    <basicUdiDi>0827002WCM00000000012MF</basicUdiDi>
    <tradeName>Cannulatome II® PC Double Lumen Sphincterotome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CT-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:22.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002268500</udiDi>
    <basicUdiDi>0827002WCM00000000048N4</basicUdiDi>
    <tradeName>Howell D.A.S.H® Sphincterotome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DASH-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:45:58.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002319035</udiDi>
    <basicUdiDi>0827002WCM00000000048N4</basicUdiDi>
    <tradeName>Fusion® OMNI-TOME Sphincterotome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-OMNI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:44:59.008Z</lastUpdated>
  </row>
</eudamedExport>