<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04714123020802</udiDi>
    <basicUdiDi>471412302IN-01T3</basicUdiDi>
    <tradeName>Insufflation Needle</tradeName>
    <deviceName>Insufflation Needle</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VERESS NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IN-120</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:38.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123020796</udiDi>
    <basicUdiDi>471412302DI-01Q9</basicUdiDi>
    <tradeName>Endoscopic Instruments-Dissector</tradeName>
    <deviceName>Endoscopic Instruments-Dissector</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY DISSECTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI-5770-33C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:38.176Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123020758</udiDi>
    <basicUdiDi>471412302EI-01QL</basicUdiDi>
    <tradeName>Endoscopic Instruments- Scissors</tradeName>
    <deviceName>Endoscopic Instruments- Scissors</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000007081</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI-330S</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:37.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123020000</udiDi>
    <basicUdiDi>471412302TR-01XQ</basicUdiDi>
    <tradeName>Trocar Stability Sleeve</tradeName>
    <deviceName>Trocar</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>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T21:12:36.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025517</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12B1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:20.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025593</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:04.604Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025616</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:53:03.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025586</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12U1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:44.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025630</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12UX1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:52:33.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025647</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-11B1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:51:08.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025562</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:46.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025494</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:45.312Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025524</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-12X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:44.129Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025531</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-12V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:29.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025500</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-11V1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:17.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025609</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-11V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:16.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025623</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-11VX1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:07.881Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025579</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:07.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025548</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-11X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:50:06.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025432</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRS-06</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-30T19:49:54.139Z</lastUpdated>
  </row>
</eudamedExport>