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Prelude Roadster™ 00884450532577

by Merit Medical Systems, Inc.

Ref PG8F45SXModel Prelude Roadster™

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

2 May 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 778246 Date17 Aug 2026IssuedStatusActive expires 2 May 2029
United StatesGUDID listing GUDID Number00884450844366 UDI-DI Date28 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 778246 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    17 Aug 2026
    Expires
    2 May 2029
    Reason
    Other

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Prelude Roadster™
Generic Name
Vascular catheter introduction set, nonimplantable
Device Name
Prelude Roadster Guide Sheath
Model / Ref / Catalog
Prelude Roadster™, PG8F45SX, 00884450532577
Primary DI / UDI-DI
00884450844366 EUDAMED
00884450532577 GUDID
Basic UDI-DI
0884450BUDI386QA
FDA Product Code
DYB, DRE
EMDN Code
C01020101 Central i.v. single-lumen catheters, peripheral access
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1340, 870.1310
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Prelude Roadster™
PG8F45SX
GUDID
00884450532577
Primary DI / UDI-DIEUDAMED
00884450844366
GUDID
00884450532577
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Animal Tissues
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (16)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No