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    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012017</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <reference>ST0425N</reference>
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    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
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    <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>UNKNOWN</legislation>
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    <reference>ST0720N</reference>
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    <deviceName></deviceName>
    <manufacturerName>Leo Medical Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <reference>ST0725N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:20.273Z</lastUpdated>
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    <udiDi>06923646505279</udiDi>
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    <deviceName></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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0730N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:44:20.252Z</lastUpdated>
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    <udiDi>06923646569615</udiDi>
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    <deviceName></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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0420R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:34:27.191Z</lastUpdated>
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    <deviceName></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>UNKNOWN</legislation>
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    <reference>ST0425R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:34:27.168Z</lastUpdated>
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    <udiDi>06923646569639</udiDi>
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    <deviceName></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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <reference>ST0430R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:34:27.146Z</lastUpdated>
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    <udiDi>06923646569653</udiDi>
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    <deviceName></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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040299</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0720R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:34:27.126Z</lastUpdated>
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    <udiDi>06923646569660</udiDi>
    <basicUdiDi>69236465L05YW</basicUdiDi>
    <tradeName>06923646569660</tradeName>
    <deviceName></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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040299</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0725R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:34:27.111Z</lastUpdated>
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    <udiDi>06923646569677</udiDi>
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    <deviceName></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>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G03040299</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST0730R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T13:34:27.090Z</lastUpdated>
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    <udiDi>04044503006660</udiDi>
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    <tradeName>PAP1-C2-25-35-OL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146567</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:42.236Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008444</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:42.214Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146568</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:42.192Z</lastUpdated>
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    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146621</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:42.170Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146561</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:42.155Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146562</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:41.791Z</lastUpdated>
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    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146619</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:41.771Z</lastUpdated>
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    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146708</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:41.754Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>FUJIFILM medwork GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>G03040201</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, DOUBLE-LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70100146601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T22:34:41.351Z</lastUpdated>
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