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Single Use Biliary Stent V PBD-V621R-1015

by Olympus Medical Systems Corporation EUDAMEDGUDID

Active European Union

Ref N1095830

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170185250 Basic UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170185250 UDI-DIDate21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Single Use Biliary Stent V PBD-V621R-1015 EUDAMED
Single Use Biliary Stent V GUDID
Generic Name
Polymeric biliary stent, non-bioabsorbable
Device Name
Biliary Drainage Tubes/ Stent
Model / Reference
N1095830 EUDAMED
PBD-V621R-1015 GUDID
Primary DI / UDI-DI
04953170185250
Basic UDI-DI
B-04953170185250
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
N1095830
GUDID
PBD-V621R-1015
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

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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