<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809399745958</udiDi>
    <basicUdiDi>B-08809399745958</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>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ODB-01</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:48:02.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809399745910</udiDi>
    <basicUdiDi>B-08809399745910</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>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FDB-02</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:47:59.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292649279</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292649279</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO02220</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:04.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292649286</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292649286</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO02210</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:04.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292649293</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292649293</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO02211</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:04.146Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292649309</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292649309</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO02212</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:04.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663251</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663251</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00007</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:03.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663299</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663299</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00062</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:03.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663305</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663305</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00401</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:03.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663312</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663312</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00012</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:03.064Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663329</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663329</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00402</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:03.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663336</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663336</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00013</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663343</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663343</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00403</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.943Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663350</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663350</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00014</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663367</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663367</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00404</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663374</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663374</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00015</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663381</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663381</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00405</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663398</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663398</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00016</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663404</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663404</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00406</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950292663411</udiDi>
    <basicUdiDi>695029260003012K2</basicUdiDi>
    <tradeName>06950292663411</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen World Surgery Medical Device Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017319</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0916</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WDTO00017</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-09T07:59:02.334Z</lastUpdated>
  </row>
</eudamedExport>