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Bioripar - Bovine Pericardium Membrane

by Assut Europe SpA 85 variants

Ref AEPB(F)100-100U

Active European Union

CE MDR

Valid until

7 Aug 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier ISTITUTO SUPERIORE DI SANITA'

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberCSQ0013236626 Date28 Sep 2026IssuedStatusActive expires 7 Aug 2028

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • CSQ0013236626 Active Supplemented

    Quality management system EU MDR

    Issued
    28 Sep 2026
    Expires
    7 Aug 2028
    Reason
    Add device or group
  • CVD002023 Active

    Technical documentation EU MDR

    Issued
    28 Nov 2023
    Expires
    7 Aug 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
AEPB(F)100-100U
Primary DI / UDI-DI
08033439381794
Basic UDI-DI
8033439BIORIPARBOVINOVN
Direct Marketing DI
08033439381794
EMDN Code
P900399 Tissue patches - other
Device Class
Class III
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000018178

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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