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Niti-S Biliary Uncovered Stent [D-Type]

by Taewoong Medical Co., Ltd. 31 variants

Ref TD0805

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K073667↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809233100431 Basic UDI-DI 08809233100431UDI-DIDate27 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08809233100431 UDI-DI Date10 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK073667 Date19 Nov 2008IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Niti-S Biliary Uncovered Stent [D-Type] EUDAMED
Niti-S Biliary Stent GUDID
Generic Name
Bare-metal biliary stent
Model / Ref / Catalog
TD0805
Primary DI / UDI-DI
08809233100431
Basic UDI-DI
B-08809233100431
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
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 50 Millimeter
Outer Diameter — 8 Millimeter
Catheter Gauge — 8 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Other devices from Taewoong Medical

See all devices from Taewoong Medical →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No