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Pascal

by Edwards Lifesciences LLC United States EUDAMED

Ref 20000IS

EMDN P0799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0690103S004PAS000BC Basic UDI-DIDate26 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 3828128TD02 Amended

    Technical documentation EU MDR

    Notified body
    Notified body 0344
    Issued
    13 Apr 2023
    Expires
    4 Aug 2027
    Reason
    Mnf ar change

Specification

EUDAMED · synced 24 Oct 2026

Device Name
PASCAL Precision
Model / Reference
20000IS
Primary DI / UDI-DI
00690103213317
Basic UDI-DI
0690103S004PAS000BC
EMDN Code
P0799 Vascular and cardiac prostheses - other
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
Other properties (11)
  • 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

Sources (1)

  • EUDAMED 00690103213317|0690103S004PAS000BC 61 fields · synced 24 Oct 2026