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    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
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    <reference>M00532810</reference>
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    <lastUpdated>2026-07-15T20:08:06.866Z</lastUpdated>
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    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <tradeName>Autotome™</tradeName>
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    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
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    <reference>M00584380</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:36.674Z</lastUpdated>
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    <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>
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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>
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    <reference>M00584150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:14.064Z</lastUpdated>
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    <basicUdiDi>B-00827002315396</basicUdiDi>
    <tradeName>00827002315396</tradeName>
    <deviceName>FUSION TRIPLE LUMEN NEEDLE KNIFE</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
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    <reference>FS-PRECUT</reference>
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    <deviceName>HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE</deviceName>
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    <reference>HPC-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:31:02.168Z</lastUpdated>
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    <udiDi>06941112309213</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
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    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0420N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:29:10.288Z</lastUpdated>
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    <udiDi>06959664934401</udiDi>
    <basicUdiDi>695966495091000016F</basicUdiDi>
    <tradeName>06959664934401</tradeName>
    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Hangzhou AGS MedTech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011718</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-50917-0530-W3545</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T15:28:20.110Z</lastUpdated>
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    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Hangzhou AGS MedTech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011718</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-50916-0530-W3545</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T15:28:12.911Z</lastUpdated>
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    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Hangzhou AGS MedTech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011718</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-50913-0530-W3545</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T15:28:11.714Z</lastUpdated>
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    <deviceName>Sphincterotome</deviceName>
    <manufacturerName>Hangzhou AGS MedTech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011718</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG-50913-0530-W3526</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T15:28:09.293Z</lastUpdated>
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    <deviceName>Sphincterotome</deviceName>
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    <lastUpdated>2026-06-29T15:28:08.100Z</lastUpdated>
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    <lastUpdated>2026-06-29T15:27:56.109Z</lastUpdated>
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