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<eudamedExport entity="devices">
  <row>
    <udiDi>08800209315996</udiDi>
    <basicUdiDi>88000406BA8J</basicUdiDi>
    <tradeName>KSIII BA Implant</tradeName>
    <deviceName>BA Implant System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KS3S3508B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:40.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800209300169</udiDi>
    <basicUdiDi>88000406SAA5</basicUdiDi>
    <tradeName>SSII SA Implant</tradeName>
    <deviceName>SA Implant System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASS2R4007S18</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:38.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040644101</udiDi>
    <basicUdiDi>88000406OBNSML</basicUdiDi>
    <tradeName>Bone Screw Non-Sterilization Bulk</tradeName>
    <deviceName>OssBuilder System (Non-Sterile)</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSCH1203NB</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:06.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040651550</udiDi>
    <basicUdiDi>88000406MSAP</basicUdiDi>
    <tradeName>MS SA IMPLANT (DENTURE)</tradeName>
    <deviceName>MS Implant System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSD2008S10</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:04.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800040607946</udiDi>
    <basicUdiDi>88000406ORTHPY</basicUdiDi>
    <tradeName>OrthAnchor</tradeName>
    <deviceName>OrthAnchor System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSBH1406</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:24:02.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000946429</udiDi>
    <basicUdiDi>88000406DRILL1EU</basicUdiDi>
    <tradeName>Screw Removal Drill</tradeName>
    <deviceName>Surgical Drill System (Single use)</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>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSRD08L</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:57.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000944579</udiDi>
    <basicUdiDi>88000406CLASSIRKITUH</basicUdiDi>
    <tradeName>Bone Spreader KIT</tradeName>
    <deviceName>Reusable Surgical Instrument KIT System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBSOK</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:55.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000941431</udiDi>
    <basicUdiDi>88000406DRILLKITSYSTEMD6</basicUdiDi>
    <tradeName>Oneday KIT</tradeName>
    <deviceName>Surgical KIT System</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>MDR 2017/745</legislation>
    <emdnCode>L159016</emdnCode>
    <emdnDescription>DENTAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HODK</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:54.264Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000930473</udiDi>
    <basicUdiDi>88000406TOOLQD</basicUdiDi>
    <tradeName>Machine Screw Driver</tradeName>
    <deviceName>Tool System</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>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMSD05L</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:52.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000929569</udiDi>
    <basicUdiDi>88000406CLASSIRGM</basicUdiDi>
    <tradeName>BONE MILL</tradeName>
    <deviceName>Reusable Surgical Instrument System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABM</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:50.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000926193</udiDi>
    <basicUdiDi>88000406DRILLH5</basicUdiDi>
    <tradeName>Twist Drill</tradeName>
    <deviceName>Surgical Drill System</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>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2D1518FNLC</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:48.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000920962</udiDi>
    <basicUdiDi>88000406OB9T</basicUdiDi>
    <tradeName>Healing Cap</tradeName>
    <deviceName>OssBuilder System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMHA444R</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:46.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000908021</udiDi>
    <basicUdiDi>88000406MSPWN</basicUdiDi>
    <tradeName>MS Implant Provisional</tradeName>
    <deviceName>MS Implant (Provisional)</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MST25154</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:45.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000903798</udiDi>
    <basicUdiDi>88000406CLASSIBUSANHY</basicUdiDi>
    <tradeName>US Esthetic-low Plastic Cylinder</tradeName>
    <deviceName>Impression Tool System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MEPR200TH</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:44.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000901152</udiDi>
    <basicUdiDi>88000406CLASSIBS25V</basicUdiDi>
    <tradeName>GS Angled Abutment Selector</tradeName>
    <deviceName>Surgical Instrument System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159099</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSAAS5520B</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:41.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000903552</udiDi>
    <basicUdiDi>88000406CSHAKX</basicUdiDi>
    <tradeName>SS Healing Abutment</tradeName>
    <deviceName>Healing Abutment System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSH605</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:38.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800000900537</udiDi>
    <basicUdiDi>88000406ABUTMENTRZ</basicUdiDi>
    <tradeName>EbonyGold Abutment Screw</tradeName>
    <deviceName>Dental Abutment System</deviceName>
    <manufacturerName>OSSTEM IMPLANT Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000020006</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ASR200W</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:22:37.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800342288904</udiDi>
    <basicUdiDi>88000406ABUTMENTRZ</basicUdiDi>
    <tradeName>T02 Pre-Milled Abutment Set</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0217MTA4825TH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:42:48.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800271288440</udiDi>
    <basicUdiDi>88000406ABUTMENTRZ</basicUdiDi>
    <tradeName>T02 Multi Angled Abutment Set</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0217MTA4835TH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:41:48.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800342288911</udiDi>
    <basicUdiDi>88000406ABUTMENTRZ</basicUdiDi>
    <tradeName>T02 Multi Angled Abutment Set</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P01020101</emdnCode>
    <emdnDescription>DENTAL IMPLANTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0217MTA4845TH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:41:47.931Z</lastUpdated>
  </row>
</eudamedExport>