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    <tradeName>06941112309671</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0730R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:43.854Z</lastUpdated>
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    <udiDi>06941112309664</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>G03040202</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0725R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:42.659Z</lastUpdated>
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    <basicUdiDi>69411123L22TG</basicUdiDi>
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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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0720R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:41.463Z</lastUpdated>
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    <udiDi>06941112309633</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
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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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0430R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:40.244Z</lastUpdated>
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    <udiDi>06941112309626</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
    <tradeName>06941112309626</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0425R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:39.161Z</lastUpdated>
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  <row>
    <udiDi>06941112309619</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
    <tradeName>06941112309619</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0420R</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:37.851Z</lastUpdated>
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    <udiDi>06941112309275</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
    <tradeName>06941112309275</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0730N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:36.641Z</lastUpdated>
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    <udiDi>06941112309268</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
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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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0725N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:35.469Z</lastUpdated>
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    <udiDi>06941112309251</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
    <tradeName>06941112309251</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0720N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:34.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941112309237</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
    <tradeName>06941112309237</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0430N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:33.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941112309220</udiDi>
    <basicUdiDi>69411123L22TG</basicUdiDi>
    <tradeName>06941112309220</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>G03040202</emdnCode>
    <emdnDescription>PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RST0425N</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-24T23:56:31.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729103301</udiDi>
    <basicUdiDi>01915060000000000000523N5</basicUdiDi>
    <tradeName>Ultratome™</tradeName>
    <deviceName></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>M00535910</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:50.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729103318</udiDi>
    <basicUdiDi>01915060000000000000523N5</basicUdiDi>
    <tradeName>Ultratome™</tradeName>
    <deviceName></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>M00535920</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:50.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729103349</udiDi>
    <basicUdiDi>01915060000000000000523N5</basicUdiDi>
    <tradeName>Ultratome™</tradeName>
    <deviceName></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>M00535930</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:50.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729121251</udiDi>
    <basicUdiDi>01915060000000000000521MZ</basicUdiDi>
    <tradeName>Jagtome™</tradeName>
    <deviceName></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>M00573540</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:50.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729121268</udiDi>
    <basicUdiDi>01915060000000000000521MZ</basicUdiDi>
    <tradeName>Jagtome™</tradeName>
    <deviceName></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>M00573550</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:50.558Z</lastUpdated>
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  <row>
    <udiDi>08714729121275</udiDi>
    <basicUdiDi>01915060000000000000521MZ</basicUdiDi>
    <tradeName>Jagtome™</tradeName>
    <deviceName></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>M00573570</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:50.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729283799</udiDi>
    <basicUdiDi>01915060000000000000522N3</basicUdiDi>
    <tradeName>RX</tradeName>
    <deviceName></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>M00545840</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:48.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729415138</udiDi>
    <basicUdiDi>01915060000000000000520MX</basicUdiDi>
    <tradeName>Autotome™</tradeName>
    <deviceName></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>M00545150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:47.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729415152</udiDi>
    <basicUdiDi>01915060000000000000520MX</basicUdiDi>
    <tradeName>Autotome™</tradeName>
    <deviceName></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>M00545160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:14:47.367Z</lastUpdated>
  </row>
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