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Balloon Trocar

by Lagis Enterprise Co., Ltd. Taiwan EUDAMED

Ref TRB-12UX1Model TRB/TRS Series

EMDN K01010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471412302TRB-01XT Basic UDI-DIDate3 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
TRB/TRS Series, TRB-12UX1
Primary DI / UDI-DI
04714123025630
Basic UDI-DI
471412302TRB-01XT
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

Other devices from Lagis Enterprise Co., Ltd.

See all devices from Lagis Enterprise Co., Ltd. →

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 04714123025630|471412302TRB-01XT 61 fields · synced 24 Oct 2026