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EGIS Biliary Flared Fully Covered Stent

by Vasnova Inc. South Korea EUDAMED

Ref FFEC08120

EMDN P0502

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800038119529 Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
FFEC08120
Primary DI / UDI-DI
08800038119529
Basic UDI-DI
B-08800038119529
EMDN Code
P0502 Biliary and pancreatic prostheses
Device Class
Class IIb
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
KR-MF-000015781
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Vasnova Inc.

See all devices from Vasnova Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (9)
  • 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 e8e43311-3e96-438c-af61-6699a59b7781 61 fields · synced 25 Oct 2026