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Prelude Roadster™

by Merit Medical Systems, Inc. United States EUDAMED

Ref PG8F90SX/BModel Prelude Roadster™

EMDN C01020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0884450BUDI386QA Basic UDI-DIDate30 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 778246 Supplemented

    Technical documentation EU MDR

    Notified body
    Notified body 2797
    Issued
    17 Aug 2026
    Expires
    2 May 2029
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Prelude Roadster Guide Sheath
Model / Reference
Prelude Roadster™, PG8F90SX/B
Primary DI / UDI-DI
00884450844380
Basic UDI-DI
0884450BUDI386QA
EMDN Code
C01020101 Central i.v. single-lumen catheters, peripheral access
Device Class
Class III
Market of Registration
Austria

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
  • CMR Substance
  • Animal Tissues
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 00884450844380|0884450BUDI386QA 61 fields · synced 24 Oct 2026