<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04714123025241</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Optical Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRA-06VL2-N</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025258</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Optical Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRA-06VX1</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025265</udiDi>
    <basicUdiDi>471412302CRS-01UM</basicUdiDi>
    <tradeName>Transanal Access Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRS-A01XS</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025272</udiDi>
    <basicUdiDi>471412302CRS-01UM</basicUdiDi>
    <tradeName>Transanal Access Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRS-60-0220S</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025289</udiDi>
    <basicUdiDi>471412302CRS-01UM</basicUdiDi>
    <tradeName>Transanal Access Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRS-60-0220XS</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025555</udiDi>
    <basicUdiDi>471412302TRB-01XT</basicUdiDi>
    <tradeName>Balloon Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12BX1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029010</udiDi>
    <basicUdiDi>471412302TRV-014A</basicUdiDi>
    <tradeName>Transvaginal Access Port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRV-0310R</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029027</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Shielded Bladed Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRC-11S1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029065</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Optical Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRC-06V2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029072</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Optical Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRC-06VL2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029089</udiDi>
    <basicUdiDi>471412302WR-01YR</basicUdiDi>
    <tradeName>Wound Retractor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR-110M-A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029096</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Optical Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>OPTICAL TROCAR, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRC-06VL2-N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029102</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Dilating Tip Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRE-06D1-N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:40.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029119</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Dilating Tip Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRE-06D2</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029126</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Dilating Tip Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRE-06D2-N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029133</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Dilating Tip Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRE-06DL2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029140</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Dilating Tip Trocar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRE-06DL2-N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029157</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Mini Trocar Smooth Sleeve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRC-03-N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029164</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Mini Trocar Smooth Sleeve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRC-03M</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029171</udiDi>
    <basicUdiDi>471412302CP-01RF</basicUdiDi>
    <tradeName>Cap for Wound Retractor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-110M</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-07T13:41:39.818Z</lastUpdated>
  </row>
</eudamedExport>