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DuraGen® Suturable

by Integra LifeSciences Corporation

Ref DURS1391ITL

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10381780258117 Basic UDI-DI 10381780258117UDI-DIDate11 Sep 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
DuraGen Plus Adhesion Barrier Matrix and Suturable DuraGen Dural Regeneration Matrix
Model / Reference
DURS1391ITL
Primary DI / UDI-DI
10381780258117
Basic UDI-DI
B-10381780258117
EMDN Code
P900402 Resorbable filling and reconstruction devices
Device Class
Class III
EU market of registration
Belgium

Manufacturer details

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

Other devices from Integra Lifesciences Corporation

See all devices from Integra Lifesciences Corporation →

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