Skip to content

DuraGen® Plus

by Integra LifeSciences Corporation EUDAMED

Active European Union

Ref DP-1011-I

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10381780026143 Basic UDI-DIDate4 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

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.

Specification

EUDAMED

Device Name
DuraGen Plus Adhesion Barrier Matrix and Suturable DuraGen Dural Regeneration Matrix
Model / Reference
DP-1011-I
Primary DI / UDI-DI
10381780026143
Basic UDI-DI
B-10381780026143
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
US-MF-000007196
Authorised representative
Integra LifeSciences Services FR-AR-000002474

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Sterile
  • Implantable
  • Animal Tissues

Other properties (10)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No