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Bladeless balloon trocar

by Unimax Medical Systems Inc. Taiwan EUDAMED

Ref FBT610100 EMDN K01010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04714127862743 Basic UDI-DIDate18 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Bladeless balloon trocar
Model / Reference
FBT610100
Primary DI / UDI-DI
04714127862743
Basic UDI-DI
B-04714127862743
EMDN Code
K01010101 Trocar standard, single-use
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000008895
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Unimax Medical Systems Inc.

See all devices from Unimax Medical Systems Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 04714127862743|B-04714127862743 61 fields · synced 25 Oct 2026