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<eudamedExport entity="devices">
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    <udiDi>08053847153455</udiDi>
    <basicUdiDi>805228249SURGICALBOXESWX</basicUdiDi>
    <tradeName>MDI</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1808</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:54:56.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108265</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>ULTRA KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HULTRK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:56.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108494</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>122 Taper Full KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H122TPFK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:56.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108500</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>122 TAPER KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H122TPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108517</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>123 Straight KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H123FK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108524</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>123 Straight Simple KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H123K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108531</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>123 Straight Full KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H123STFK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108548</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>485 KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H485K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108555</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>MS KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMISLK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917108586</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>TAPER KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HTAPEK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917110527</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>Positioning Guide Full KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPGAK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917110534</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>Positioning Guide KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPGPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:55.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917147363</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>Positioning Guide Full KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPGAK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:53.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809917147370</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>Positioning Guide KIT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPGPK</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T17:46:53.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800041367443</udiDi>
    <basicUdiDi>B-08800041367443</basicUdiDi>
    <tradeName>Sidecut Drill</tradeName>
    <deviceName>Sidecut Drill</deviceName>
    <manufacturerName>SEWONMEDIX Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000016194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHSCDS30L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:01.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800041367436</udiDi>
    <basicUdiDi>B-08800041367436</basicUdiDi>
    <tradeName>Sidecut Drill</tradeName>
    <deviceName>Sidecut Drill</deviceName>
    <manufacturerName>SEWONMEDIX Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000016194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHSCDS25L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:25:00.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800041367429</udiDi>
    <basicUdiDi>B-08800041367429</basicUdiDi>
    <tradeName>Sidecut Drill</tradeName>
    <deviceName>Sidecut Drill</deviceName>
    <manufacturerName>SEWONMEDIX Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000016194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHSCDS25S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:24:59.743Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800041367412</udiDi>
    <basicUdiDi>B-08800041367412</basicUdiDi>
    <tradeName>Sidecut Drill</tradeName>
    <deviceName>Sidecut Drill</deviceName>
    <manufacturerName>SEWONMEDIX Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000016194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHSCDS20L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:24:58.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800041367405</udiDi>
    <basicUdiDi>B-08800041367405</basicUdiDi>
    <tradeName>Sidecut Drill</tradeName>
    <deviceName>Sidecut Drill</deviceName>
    <manufacturerName>SEWONMEDIX Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000016194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHSCDS20S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:24:54.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800041366859</udiDi>
    <basicUdiDi>B-08800041366859</basicUdiDi>
    <tradeName>Bone Trimmer</tradeName>
    <deviceName>Bone Trimmer</deviceName>
    <manufacturerName>SEWONMEDIX Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000016194</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBT50</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T22:23:03.560Z</lastUpdated>
  </row>
</eudamedExport>