<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04714123023223</udiDi>
    <basicUdiDi>471412302SAP-01UM</basicUdiDi>
    <tradeName>Electrosurgical Suction Irrigation System</tradeName>
    <deviceName>Electrosurgical Suction Irrigation System</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>K0201010302</emdnCode>
    <emdnDescription>LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIP-340-N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:47.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022240</udiDi>
    <basicUdiDi>471412302WR-01YR</basicUdiDi>
    <tradeName>Wound Retractor</tradeName>
    <deviceName>Wound Retractor</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>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR-80S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:43.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022165</udiDi>
    <basicUdiDi>471412302TRL-0124</basicUdiDi>
    <tradeName>Multiple Instrument Access Port</tradeName>
    <deviceName>Multiple Instrument Access Port</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>K01010199</emdnCode>
    <emdnDescription>TROCAR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRL-0310R</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:42.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022059</udiDi>
    <basicUdiDi>471412302LC-01RP</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-0002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:42.150Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123020017</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-06L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:41.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029447</udiDi>
    <basicUdiDi>471412302EBS-01PX</basicUdiDi>
    <tradeName>Tissue containment bag</tradeName>
    <deviceName>Tissue Containment Bag</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>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBS-0810</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:59.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123029300</udiDi>
    <basicUdiDi>471412302MG-01SW</basicUdiDi>
    <tradeName>Mini Laparoscopy Grasping Device</tradeName>
    <deviceName>Mini Laparoscopy Grasping Device</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>K01020104</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MG-1801</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:55.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123024534</udiDi>
    <basicUdiDi>471412302TRB-01XT</basicUdiDi>
    <tradeName>Balloon Trocar</tradeName>
    <deviceName>Balloon 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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRB-12V1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:53.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123024091</udiDi>
    <basicUdiDi>471412302SA-01TN</basicUdiDi>
    <tradeName>Suction Irrigation System</tradeName>
    <deviceName>Suction Irrigation System</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>K01020110</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-520C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:52.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123023384</udiDi>
    <basicUdiDi>471412302LB-01RG</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic Kit-LB Kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LB-1100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:48.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123023216</udiDi>
    <basicUdiDi>471412302SAP-01UM</basicUdiDi>
    <tradeName>Electrosurgical Suction Irrigation System</tradeName>
    <deviceName>Electrosurgical Suction Irrigation System</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>K0201010302</emdnCode>
    <emdnDescription>LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SIP-340-L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:47.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123023063</udiDi>
    <basicUdiDi>471412302CRS-01UM</basicUdiDi>
    <tradeName>Transanal Access Port</tradeName>
    <deviceName>Transanal Access Port</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>K01010199</emdnCode>
    <emdnDescription>TROCAR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CRS-60-0220M</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:46.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022172</udiDi>
    <basicUdiDi>471412302WR-01YR</basicUdiDi>
    <tradeName>Wound Retractor</tradeName>
    <deviceName>Wound Retractor</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>K01020106</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SPREADERS AND RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WR-60ES</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:45.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022158</udiDi>
    <basicUdiDi>471412302TRL-0124</basicUdiDi>
    <tradeName>Multiple Instrument Access Port</tradeName>
    <deviceName>Multiple Instrument Access Port</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>K01010199</emdnCode>
    <emdnDescription>TROCAR, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRL-0220R</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:41.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022042</udiDi>
    <basicUdiDi>471412302LC-01RP</basicUdiDi>
    <tradeName>Laparoscopic Kit</tradeName>
    <deviceName>Laparoscopic kit</deviceName>
    <manufacturerName>Lagis Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-PR-000026825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020120</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LC-0001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:40.834Z</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>K01010101</emdnCode>
    <emdnDescription>TROCAR STANDARD, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR-06</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:32:40.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022806</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>K0180</emdnCode>
    <emdnDescription>ENDOTHERAPY DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP-60ES</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:30:14.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123021441</udiDi>
    <basicUdiDi>471412302DI-02QB</basicUdiDi>
    <tradeName>Endoscopic Instrument - Grasper</tradeName>
    <deviceName>Endoscopic Instruments - Grasper</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>K01020104</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DI-5716-33D</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:30:13.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123022493</udiDi>
    <basicUdiDi>471412302BFI-01MW</basicUdiDi>
    <tradeName>Bipolar Coagulation and Cutting Forceps</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 IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>K0201010602</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFI-5330K-L</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:30:13.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123020840</udiDi>
    <basicUdiDi>471412302EB-01P3</basicUdiDi>
    <tradeName>Endo-Bag</tradeName>
    <deviceName>Endo Bag</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>K01020107</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY RECOVERY BAGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EB-0507</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:30:11.467Z</lastUpdated>
  </row>
</eudamedExport>