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<eudamedExport entity="devices">
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    <udiDi>05425025630141</udiDi>
    <basicUdiDi>542502563-ASH001-S2</basicUdiDi>
    <tradeName>HPR45i</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPR45i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:04:24.553Z</lastUpdated>
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    <udiDi>00827002210493</udiDi>
    <basicUdiDi>0827002WCM00000000017MR</basicUdiDi>
    <tradeName>Hemospray® Endoscopic Hemostat</tradeName>
    <deviceName>Hemospray Endoscopic Hemostat</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>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEMO-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:46:31.115Z</lastUpdated>
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    <udiDi>08800038404687</udiDi>
    <basicUdiDi>B-08800038404687</basicUdiDi>
    <tradeName>Nexpowder™ Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EU-2522</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:27:38.320Z</lastUpdated>
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    <udiDi>08800038405189</udiDi>
    <basicUdiDi>88000384NHS03JR</basicUdiDi>
    <tradeName>Nexpowder™ Hemostatic System for Endoscopy</tradeName>
    <deviceName>Nexpowder™ Hemostatic System for Endoscopy</deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NHS03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:13.853Z</lastUpdated>
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  <row>
    <udiDi>08800038404373</udiDi>
    <basicUdiDi>B-08800038404373</basicUdiDi>
    <tradeName>Nexpowder™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UI-EWD3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:23.381Z</lastUpdated>
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  <row>
    <udiDi>08800038404366</udiDi>
    <basicUdiDi>B-08800038404366</basicUdiDi>
    <tradeName>Nexpowder™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UI-EWD2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:22.166Z</lastUpdated>
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  <row>
    <udiDi>08800038404359</udiDi>
    <basicUdiDi>B-08800038404359</basicUdiDi>
    <tradeName>Nexpowder™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UI-EWD1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:20.960Z</lastUpdated>
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  <row>
    <udiDi>06954790923060</udiDi>
    <basicUdiDi>695479092347P6</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges-Elastic thread</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZF-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:40.674Z</lastUpdated>
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  <row>
    <udiDi>06954790923053</udiDi>
    <basicUdiDi>695479092353NZ</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZJ-7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:39.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954790923046</udiDi>
    <basicUdiDi>695479092353NZ</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZJ-6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:33.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954790923039</udiDi>
    <basicUdiDi>695479092353NZ</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZJ-5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:32.252Z</lastUpdated>
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  <row>
    <udiDi>06954790923022</udiDi>
    <basicUdiDi>695479092353NZ</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZJ-4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:31.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954790923015</udiDi>
    <basicUdiDi>695479092347P6</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges-Elastic thread</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZF-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:29.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>06954790923008</udiDi>
    <basicUdiDi>695479092353NZ</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZJ-8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:23.849Z</lastUpdated>
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  <row>
    <udiDi>06954790922995</udiDi>
    <basicUdiDi>695479092353NZ</basicUdiDi>
    <tradeName>Disposable Anorectal Ligation Devices and Cartridges</tradeName>
    <deviceName>Disposable Anorectal Ligation Devices and Cartridges</deviceName>
    <manufacturerName>Changzhou Tongchuang Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028788</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TCTZJ-3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:22:22.649Z</lastUpdated>
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  <row>
    <udiDi>00827002565722</udiDi>
    <basicUdiDi>0827002WCM00000000017MR</basicUdiDi>
    <tradeName>Hemospray® Endoscopic Hemostat</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>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEMO-7</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:45:24.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630608</udiDi>
    <basicUdiDi>542502563-ASH001-S2</basicUdiDi>
    <tradeName>Rafaeloprobe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rafaelo probe</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:53.690Z</lastUpdated>
  </row>
  <row>
    <udiDi>05425025630615</udiDi>
    <basicUdiDi>542502563-ASH001-S2</basicUdiDi>
    <tradeName>Sphera probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>F Care Systems</manufacturerName>
    <manufacturerSrn>BE-MF-000000037</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Sphera probe</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-20T12:57:53.672Z</lastUpdated>
  </row>
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    <udiDi>08800038405325</udiDi>
    <basicUdiDi>88000384NHS03JR</basicUdiDi>
    <tradeName>Nexpowder™ Hemostatic System for Endoscopy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T00:20:48.904Z</lastUpdated>
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  <row>
    <udiDi>08800038405332</udiDi>
    <basicUdiDi>88000384NHS03JR</basicUdiDi>
    <tradeName>Nexpowder™ Hemostatic System for Endoscopy</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020499</emdnCode>
    <emdnDescription>GASTROINTESTINAL HAEMOSTASIS DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T00:20:48.881Z</lastUpdated>
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