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ALLEGRA Transcatheter Heart Valve

by NVT GmbH 2 variants

Ref THV-AO0023G1RE, THV-AO0031G1REModel ALLEGRA THV

Expiring European Union

CE MDR

Valid until

28 Jul 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number51380-60-04-00 Date1 Aug 2025IssuedStatusActive expires 20 Sep 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 51380-60-04-00 Active

    Quality management system EU MDR

    Certifier
    DEKRA Certification GmbH 0124
    Issued
    1 Aug 2025
    Expires
    20 Sep 2030
    Valid from
    21 Sep 2025
  • 51380-61-B0-01 Expiring Expires in 269 days

    Technical documentation EU MDR

    Certifier
    DEKRA Certification GmbH 0124
    Issued
    25 Mar 2025
    Expires
    28 Jul 2027

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Device Name
ALLEGRA Transcatheter Heart Valve (THV)
Model / Reference
ALLEGRA THV, THV-AO0023G1RE, THV-AO0031G1RE
Primary DI / UDI-DI
04260508661011, 04260508661035
Basic UDI-DI
426050866THVAOXXXXG1REAC
EMDN Code
P070301030201 Stented biological aortic valves for percutaneous implant - non-valve tissue of animal origin
Device Class
Class III
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005426

Other devices from NVT GmbH

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