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Edwards EVOQUE

by Edwards Lifesciences LLC United States EUDAMED

Ref 9850EV48

EMDN P070301030104

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0690103D004EVV000Z3 Basic UDI-DIDate1 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3828128TD05 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    8 Jul 2025
    Expires
    13 Oct 2028
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
EVOQUE Valves
Model / Reference
9850EV48
Primary DI / UDI-DI
00690103212839
Basic UDI-DI
0690103D004EVV000Z3
EMDN Code
P070301030104 Stented biological tricuspid valves for percutaneous implant - valve tissue of animal origin
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007139
Authorised representative
Edwards Lifesciences GmbH DE-AR-000006184

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 00690103212839|0690103D004EVV000Z3 61 fields · synced 24 Oct 2026