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    <basicUdiDi>B-08809539691671</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-016</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:13:57.517Z</lastUpdated>
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    <udiDi>08809416063768</udiDi>
    <basicUdiDi>B-08809416063768</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-014</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:03:43.845Z</lastUpdated>
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    <udiDi>08809416063751</udiDi>
    <basicUdiDi>B-08809416063751</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-012</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:03:42.689Z</lastUpdated>
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    <udiDi>08809416061375</udiDi>
    <basicUdiDi>B-08809416061375</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDS-03</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:03:10.960Z</lastUpdated>
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    <udiDi>08809416061368</udiDi>
    <basicUdiDi>B-08809416061368</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODS-04</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:03:08.565Z</lastUpdated>
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  <row>
    <udiDi>08809416061306</udiDi>
    <basicUdiDi>B-08809416061306</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LDS-02</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:03:06.962Z</lastUpdated>
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  <row>
    <udiDi>08809416061290</udiDi>
    <basicUdiDi>B-08809416061290</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LDS-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:03:06.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399747136</udiDi>
    <basicUdiDi>B-08809399747136</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMF-L04</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:45.556Z</lastUpdated>
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  <row>
    <udiDi>08809399746153</udiDi>
    <basicUdiDi>B-08809399746153</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDS-02</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:11.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746139</udiDi>
    <basicUdiDi>B-08809399746139</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODS-02</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:09.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746122</udiDi>
    <basicUdiDi>B-08809399746122</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODS-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:08.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746115</udiDi>
    <basicUdiDi>B-08809399746115</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDS-02</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:08.219Z</lastUpdated>
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  <row>
    <udiDi>08809399746108</udiDi>
    <basicUdiDi>B-08809399746108</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName>Surgical Instrument</deviceName>
    <manufacturerName>OSTEONIC Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008969</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDS-01</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:04.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053847158696</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00377CON</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:57.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053847158030</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INN-00535/L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:57.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052282495151</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00578/DRILL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:57.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052282495144</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00578/L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:56.985Z</lastUpdated>
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  <row>
    <udiDi>08052282495137</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00578/SHORT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:56.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052282495175</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D-17018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:56.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>08052282495182</udiDi>
    <basicUdiDi>805228249DENTALDRIVERS6X</basicUdiDi>
    <tradeName>Not applicable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B. &amp; B. Dental S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000028342</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D-17024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:53:56.893Z</lastUpdated>
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