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Advanix™ Pancreatic Stent M00536760

by Boston Scientific

Ref M00536760

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

20 Aug 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3827895TD10 Date15 Sep 2026IssuedStatusActive expires 20 Aug 2029
United StatesGUDID listing GUDID Number08714729856962 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 3827895TD10 Active Amended

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Sep 2026
    Expires
    20 Aug 2029
    Reason
    Other
  • 3827895TD10 Active Removed from EUDAMED

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    20 Aug 2024
    Expires
    20 Aug 2029

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Advanix™ EUDAMED
Advanix™ Pancreatic Stent GUDID
Generic Name
Polymeric pancreatic stent, non-bioabsorbable
Model / Ref / Catalog
M00536760
Primary DI / UDI-DI
08714729856962
Basic UDI-DI
01915060000000000000270MX
FDA Product Code
FGE
EMDN Code
P0502 Biliary and pancreatic prostheses
GMDN Term
Polymeric pancreatic stent, non-bioabsorbable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.5010
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Polymeric pancreatic stent, non-bioabsorbable

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

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

Other properties (19)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Sutures: 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