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Niti-S Biliary Covered Stent [Flare-Type]

by Taewoong Medical Co., Ltd. South Korea EUDAMED

Ref BSM0805FW

EMDN P0502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08809643756204 Basic UDI-DIDate1 Jun 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 22 Oct 2026

Model / Reference
BSM0805FW
Primary DI / UDI-DI
08809643756204
Basic UDI-DI
B-08809643756204
EMDN Code
P0502 Biliary and pancreatic prostheses
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
KR-MF-000007515
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Taewoong Medical Co., Ltd.

See all devices from Taewoong Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
Other properties (11)
  • 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 1a91f6ec-7b6a-40d0-bcb0-9e93424ebb93 61 fields · synced 22 Oct 2026