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Prelude®

by Merit Medical Systems, Inc. United States EUDAMED

Ref PSI-5F-11-038-18G/JModel Prelude® EMDN C0502

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-00884450415467 Basic UDI-DIDate7 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
Prelude®, PSI-5F-11-038-18G/J
Primary DI / UDI-DI
00884450415467
Basic UDI-DI
B-00884450415467
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000001366
Authorised representative
Merit Medical Ireland Ltd IE-AR-000001011

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Animal Tissues
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00884450415467|B-00884450415467 61 fields · synced 25 Oct 2026