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Trek 1012405-12

by Abbott Vascular

Ref 1012405-12

Trek 1012405-12 is a device classified as Class III in the EU and Class II in the US made by Abbott Vascular, registered in EUDAMED on 16 Oct 2026 (Basic UDI-DI B-08717648153976) and listed in FDA GUDID since 19 Feb 2016 (UDI-DI 08717648153976), 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-08717648153976 Basic UDI-DI 08717648153976UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717648153976 UDI-DI Date19 Feb 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08717648153976 registered 16 Oct 2026 Active
  • FDA GUDID UDI-DI 08717648153976 listed 19 Feb 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08717648153976
  2. Registered EUDAMED B-08717648153976

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  • Withdrawn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
TREK OTW Coronary Dilatation Catheter EUDAMED
Trek GUDID
Generic name
Coronary angioplasty balloon catheter, basic
Model / Ref / Catalog
1012405-12
Primary DI / UDI-DI
08717648153976
Basic UDI-DI
B-08717648153976
FDA product code
LOX
EMDN code
C010401020101 Ptca balloon dilation catheters
GMDN term
Coronary angioplasty balloon catheter, basic
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.5100
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Coronary angioplasty balloon catheter, basic

Other devices from Abbott Vascular

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Properties

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