Skip to content

Single Use Biliary Stent V PBD-V621R-1005

by Olympus Medical Systems Corporation

Ref N1095430

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170185175 Basic UDI-DI 04953170185175UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170185175 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

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.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Single Use Biliary Stent V PBD-V621R-1005 EUDAMED
Single Use Biliary Stent V GUDID
Generic Name
Polymeric biliary stent, non-bioabsorbable
Device Name
Biliary Drainage Tubes/ Stent
Model / Reference
N1095430 EUDAMED
PBD-V621R-1005 GUDID
Primary DI / UDI-DI
04953170185175
Basic UDI-DI
B-04953170185175
FDA Product Code
FGE
EMDN Code
P0502 Biliary and pancreatic prostheses
GMDN Term
Polymeric biliary stent, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5010
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N1095430
GUDID
PBD-V621R-1005
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Serial Number: No
  • Manufacturing Date: No