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Destination 54-64501

by Terumo Medical Corporation

Ref 54-64501

Destination 54-64501 is a device classified as Class III in the EU and Class II in the US made by Terumo Medical Corporation, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI B-00389701008837) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00389701008837), active as of 9 Nov 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 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00389701008837 Basic UDI-DI 00389701008837UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00389701008837 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00389701008837 registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 00389701008837 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00389701008837
  2. Registered EUDAMED B-00389701008837

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  • Withdrawn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
Destination Peripheral Guiding Sheath EUDAMED
Destination GUDID
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Guiding Sheaths
Model / Ref / Catalog
54-64501
Primary DI / UDI-DI
00389701008837
Basic UDI-DI
B-00389701008837
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1340
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 45 Centimeter
Catheter Gauge — 6 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Vascular catheter introduction set, nonimplantableVascular guide-catheter, single-use

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from Terumo Medical Corporation

See all devices from Terumo Medical Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)