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ALLEGRA Delivery System TF

by NVT GmbH EUDAMED

Active European Union

Ref DSL-AO18G1RE1150Model ALLEGRA Delivery System TF

Regulatory status

as of 27 Oct 2026

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

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  • Withdrawn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)
  • 51380-60-04-00 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0124
    Issued
    1 Aug 2025
    Expires
    20 Sep 2030
    Valid from
    21 Sep 2025
  • 51380-61-C0-00 Issued

    Technical documentation EU MDR

    Notified body
    Notified body 0124
    Issued
    12 Feb 2025
    Expires
    28 Jul 2027

Specification

EUDAMED

Device Name
ALLEGRA Delivery System transfemoral (TF)
Model / Reference
ALLEGRA Delivery System TF, DSL-AO18G1RE1150
Primary DI / UDI-DI
04260508661004
Basic UDI-DI
426050866DSLAOXXG1REXXXS5
EMDN Code
P07038002 Cardiac valve transcatheter implant accessories
Device Class
Class III
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005426

Other devices from NVT GmbH

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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