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aixstent BDP

by bess pro gmbh EUDAMED

Active European Union

Ref 312-10-040

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number4063106ASTAIXMP Basic UDI-DIDate10 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 1000310118 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0297
    Issued
    2 Jul 2026
    Expires
    1 Jul 2031
  • 1000301888 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    2 Jul 2026
    Expires
    27 Feb 2030
    Reason
    Change approved

Specification

EUDAMED

Device Name
aixstent
Model / Reference
312-10-040
Primary DI / UDI-DI
14063106100619
Basic UDI-DI
4063106ASTAIXMP
EMDN Code
P0502 Biliary and pancreatic prostheses
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006209

Other devices from bess pro gmbh

See all devices from bess pro gmbh →

Properties

Show properties
  • Sterile
  • Implantable
Other properties (12)
  • 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