<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <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>
  </row>
  <row>
    <udiDi>08800038405202</udiDi>
    <basicUdiDi>B-08800038405202</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</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>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nexsphere-H</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:40.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038405196</udiDi>
    <basicUdiDi>B-08800038405196</basicUdiDi>
    <tradeName>Nexsphere-F™</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>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Nexsphere-F</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:38.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038404533</udiDi>
    <basicUdiDi>B-08800038404533</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</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>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB700</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:32.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038404526</udiDi>
    <basicUdiDi>B-08800038404526</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</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>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB500</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:31.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038404519</udiDi>
    <basicUdiDi>B-08800038404519</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</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>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB300</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:30.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800038404502</udiDi>
    <basicUdiDi>B-08800038404502</basicUdiDi>
    <tradeName>Nexsphere™</tradeName>
    <deviceName>Embolic gelatin microspheres</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>C010402020303</emdnCode>
    <emdnDescription>EMBOLISATION PARTICLES AND MICROSPHERES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UIGB100</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-01T01:55:29.397Z</lastUpdated>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-27T00:20:48.944Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <row>
    <udiDi>08800038404588</udiDi>
    <basicUdiDi>B-08800038404588</basicUdiDi>
    <tradeName>Spray Body</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEXTBIOMEDICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>KR-MF-000004808</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-26T02:45:34.988Z</lastUpdated>
  </row>
</eudamedExport>