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Transend™ M001468010

by Boston Scientific

Ref M001468010

Transend™ M001468010 is a device classified as Class IIa in the EU and Class II in the US made by Boston Scientific, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 01915060000000000000278NF) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08714729326243), active as of 7 Nov 2026.

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

CE MDR

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000278NF Basic UDI-DI 08714729326243UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729326243 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 01915060000000000000278NF registered 6 Nov 2026 Active
  • FDA GUDID UDI-DI 08714729326243 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08714729326243
  2. Registered EUDAMED 01915060000000000000278NF

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  • Withdrawn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
Transend™
Generic name
Peripheral vascular guidewire, manual
Model / reference
M001468010
Primary DI / UDI-DI
08714729326243
Basic UDI-DI
01915060000000000000278NF
FDA product code
DQX
EMDN code
C04020201 Peripheral vascular therapeutic guidewires, hydrophilic
GMDN term
Peripheral vascular guidewire, manual
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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 THERAPEUTIC GUIDEWIRES.

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)