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SplashWire™ 00884450529461

by Merit Medical Systems, Inc.

Ref MSWSTDA25260EXModel Initial Release

SplashWire™ 00884450529461 (MSWSTDA25260EX) is a device classified as Class IIa in the EU and Class II in the US made by Merit Medical Systems, Inc., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-00884450529461) and listed in FDA GUDID since 18 Feb 2022 (UDI-DI 00884450529461), active as of 24 Oct 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450529461 Basic UDI-DI 00884450529461UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450529461 UDI-DI Date18 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450529461 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 00884450529461 listed 18 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450529461
  2. Registered EUDAMED B-00884450529461

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SplashWire™
Generic name
Peripheral vascular guidewire, manual
Model / Ref / Catalog
Initial Release, MSWSTDA25260EX, 00884450529461
Primary DI / UDI-DI
00884450529461
Basic UDI-DI
B-00884450529461
FDA product code
DQX
EMDN code
C04020101 Peripheral vascular diagnostic guidewires, hydrophilic
GMDN term
Peripheral vascular guidewire, manual
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Initial Release
MSWSTDA25260EX
GUDID
00884450529461
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Peripheral vascular guidewire, manual

Similar devices in this category

Other devices filed under PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC.

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)