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    <tradeName>TRUEtome™ Dreamwire™</tradeName>
    <deviceName>TRUEtome Dreamwire Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00583180</reference>
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    <lastUpdated>2026-07-15T20:09:30.246Z</lastUpdated>
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    <tradeName>TRUEtome™</tradeName>
    <deviceName>TRUEtome Hydra Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
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    <reference>M00583160</reference>
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    <lastUpdated>2026-07-15T20:09:27.021Z</lastUpdated>
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    <tradeName>MicroKnife™</tradeName>
    <deviceName>Triple Lumen Needle Knife</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00535900</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:08:06.866Z</lastUpdated>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00584400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:37.318Z</lastUpdated>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00584380</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:36.674Z</lastUpdated>
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    <udiDi>08714729953272</udiDi>
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    <tradeName>TRUEtome™</tradeName>
    <deviceName>TRUEtome Revolution Cannulating Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00583260</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:59:02.131Z</lastUpdated>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00584150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:14.064Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <basicUdiDi>0827002WCM00000000048N4</basicUdiDi>
    <tradeName>Fusion® OMNI-TOME</tradeName>
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    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-OMNI-21</reference>
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    <lastUpdated>2026-07-14T19:44:58.443Z</lastUpdated>
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    <udiDi>00827002613508</udiDi>
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    <tradeName>SureTome™ SW Sphincterotome with DomeTip®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
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    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUR-SW-35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:44:58.053Z</lastUpdated>
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    <basicUdiDi>0827002WCM00000000048N4</basicUdiDi>
    <tradeName>Fusion® Triple Lumen Sphincterotome</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
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    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FS-25M-35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:02:43.836Z</lastUpdated>
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    <basicUdiDi>0827002WCM00000000048N4</basicUdiDi>
    <tradeName>D.A.S.H® DomeTip® 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>
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    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DASH-35</reference>
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    <lastUpdated>2026-07-13T20:02:19.833Z</lastUpdated>
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    <tradeName>Tri-Tome PC® Triple Lumen Sphincterotome</tradeName>
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    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
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    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRI-20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:07:37.104Z</lastUpdated>
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    <udiDi>06944233424148</udiDi>
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    <tradeName>Disposable Papillotome</tradeName>
    <deviceName>Disposable Papillotome</deviceName>
    <manufacturerName>Wilson Instruments (SHA) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:30:36.270Z</lastUpdated>
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