<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800012341007</udiDi>
    <basicUdiDi>88000123MEHL04109Z</basicUdiDi>
    <tradeName>08800012341007</tradeName>
    <deviceName>Head-worn light</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-410A</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:16:12.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012310126</udiDi>
    <basicUdiDi>B-08800012310126</basicUdiDi>
    <tradeName>Hi bebe plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012315015</udiDi>
    <basicUdiDi>B-08800012315015</basicUdiDi>
    <tradeName>Hi bebe super</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-150B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012320002</udiDi>
    <basicUdiDi>B-08800012320002</basicUdiDi>
    <tradeName>Hi-bebe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-200L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.923Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012320033</udiDi>
    <basicUdiDi>B-08800012320033</basicUdiDi>
    <tradeName>Hi-bebe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-200T</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012320064</udiDi>
    <basicUdiDi>B-08800012320064</basicUdiDi>
    <tradeName>Hi-dop</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-200V</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012322013</udiDi>
    <basicUdiDi>B-08800012322013</basicUdiDi>
    <tradeName>Hi-bebe S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-220C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012325007</udiDi>
    <basicUdiDi>B-08800012325007</basicUdiDi>
    <tradeName>08800012325007</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-250</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012330001</udiDi>
    <basicUdiDi>B-08800012330001</basicUdiDi>
    <tradeName>08800012330001</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-300</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012330018</udiDi>
    <basicUdiDi>B-08800012330018</basicUdiDi>
    <tradeName>08800012330018</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>Biocare FM-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012335006</udiDi>
    <basicUdiDi>B-08800012335006</basicUdiDi>
    <tradeName>08800012335006</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012335020</udiDi>
    <basicUdiDi>B-08800012335020</basicUdiDi>
    <tradeName>08800012335020</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>FM20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012340017</udiDi>
    <basicUdiDi>B-08800012340017</basicUdiDi>
    <tradeName>08800012340017</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</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>BT-400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012341014</udiDi>
    <basicUdiDi>88000123MEHL04109Z</basicUdiDi>
    <tradeName>08800012341014</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-410F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012350009</udiDi>
    <basicUdiDi>B-08800012350009</basicUdiDi>
    <tradeName>08800012350009</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012355004</udiDi>
    <basicUdiDi>B-08800012355004</basicUdiDi>
    <tradeName>08800012355004</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-550</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012371004</udiDi>
    <basicUdiDi>B-08800012371004</basicUdiDi>
    <tradeName>Gateway</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012372001</udiDi>
    <basicUdiDi>B-08800012372001</basicUdiDi>
    <tradeName>08800012372001</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-720</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.740Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012374005</udiDi>
    <basicUdiDi>B-08800012374005</basicUdiDi>
    <tradeName>08800012374005</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-740</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012377006</udiDi>
    <basicUdiDi>B-08800012377006</basicUdiDi>
    <tradeName>08800012377006</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-770</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:44:25.714Z</lastUpdated>
  </row>
</eudamedExport>