Skip to content

Niti-S Biliary Speed D Stent BDM0808

by Taewoong Medical South Korea EUDAMEDGUDID

Ref BDM0808

Product code FGEEMDN P0502

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809293835786 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809293835786 UDI-DIDate1 Jun 2023ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Niti-S Biliary Uncovered Stent [D-Type] EUDAMED
Niti-S Biliary Speed D Stent GUDID
Generic Name
Bare-metal biliary stent
Model / Reference
BDM0808
Primary DI / UDI-DI
08809293835786 EUDAMED
08809909414091 GUDID
Basic UDI-DI
B-08809293835786
510(k) Number
FDA Product Code
FGE
EMDN Code
P0502 Biliary and pancreatic prostheses
GMDN Term
Bare-metal biliary stent
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5010
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional
Size
Stent Diameter — 8 Millimeter
Stent Length — 80 Millimeter
Catheter Working Length — 180 Centimeter
Crossing Profile — 8.5 French

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
08809293835786
GUDID
08809909414091
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Bare-metal biliary stent

Cleared under the same submission (K223626)

Show all (12)

Other devices from Taewoong Medical

See all devices from Taewoong Medical →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (17)
  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No

Sources (2)

  • FDA UDI 67844a5c-67e7-4d81-933a-aa2a05f83d47 36 fields · synced 24 Oct 2026
  • EUDAMED 08809293835786|B-08809293835786 61 fields · synced 17 Oct 2026