<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809399746184</udiDi>
    <basicUdiDi>B-08809399746184</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746191</udiDi>
    <basicUdiDi>B-08809399746191</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746207</udiDi>
    <basicUdiDi>B-08809399746207</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-050</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746214</udiDi>
    <basicUdiDi>B-08809399746214</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746221</udiDi>
    <basicUdiDi>B-08809399746221</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746245</udiDi>
    <basicUdiDi>B-08809399746245</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746252</udiDi>
    <basicUdiDi>B-08809399746252</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-091</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746269</udiDi>
    <basicUdiDi>B-08809399746269</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-092</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746276</udiDi>
    <basicUdiDi>B-08809399746276</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.213Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746283</udiDi>
    <basicUdiDi>B-08809399746283</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-094</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746351</udiDi>
    <basicUdiDi>B-08809399746351</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399746368</udiDi>
    <basicUdiDi>B-08809399746368</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399747136</udiDi>
    <basicUdiDi>B-08809399747136</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMF-L04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399748508</udiDi>
    <basicUdiDi>B-08809399748508</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSF-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399748515</udiDi>
    <basicUdiDi>B-08809399748515</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSO-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399748553</udiDi>
    <basicUdiDi>B-08809399748553</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHA-4820-TAP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399748560</udiDi>
    <basicUdiDi>B-08809399748560</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHA-4820-AWL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399748676</udiDi>
    <basicUdiDi>B-08809399748676</basicUdiDi>
    <tradeName>Reusable Surgical Instrument</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACL-0329-DRIVER-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399749031</udiDi>
    <basicUdiDi>B-08809399749031</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-123</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:26.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399749048</udiDi>
    <basicUdiDi>B-08809399749048</basicUdiDi>
    <tradeName>Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IOC-122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T23:30:25.995Z</lastUpdated>
  </row>
</eudamedExport>