<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04714123029317</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-10512N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:55.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123025265</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-A01XS</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:54.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123024541</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-12VX1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:50.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123024107</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-520CT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:49.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>04714123023391</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-1101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:41:48.530Z</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>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>
</eudamedExport>