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Advanix™ Pancreatic Stent Kit M00537460

by Boston Scientific

Ref M00537460

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number3827895TD10 Date15 Sep 2026IssuedStatusActive expires 20 Aug 2029
United StatesGUDID listing GUDID Number08714729856245 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  • Withdrawn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 Kit GUDID
Generic name
Polymeric pancreatic stent, non-bioabsorbable
Device name
Advanix Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers
Model / reference
M00537460
Primary DI / UDI-DI
08714729856245
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 registration type
Standard device
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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (20)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Sutures: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No