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Universal Trocar Stability Sleeve

by Lagis Enterprise Co., Ltd. Taiwan EUDAMED

Ref TRC-12XModel TR/TRO/TRC/TRE/TRA Series

EMDN K01010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471412302TR-01XQ Basic UDI-DIDate26 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Trocar
Model / Reference
TR/TRO/TRC/TRE/TRA Series, TRC-12X
Primary DI / UDI-DI
04714123022950
Basic UDI-DI
471412302TR-01XQ
EMDN Code
K01010101 Trocar standard, single-use
Device Class
Class IIa
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
TW-MF-000007081
Authorised representative
Obelis s.a. BE-AR-000000106

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 71a6e839-fe93-4d50-96d1-c19f8915d7b0 61 fields · synced 24 Oct 2026