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Trek™ 1012274-20

by Abbott Vascular

Ref 1012274-20

Trek™ 1012274-20 is a device classified as Class III in the EU and Class II in the US made by Abbott Vascular, registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI 8717648CDC0001LW) with CE/MDR certificate MDR 762879 valid until 18 Apr 2028 and listed in FDA GUDID since 19 Feb 2016 (UDI-DI 08717648138447), active as of 24 Oct 2026.

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

CE MDR

Valid until

18 Apr 2028

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8717648CDC0001LW Basic UDI-DI 08717648138447UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717648138447 UDI-DI Date19 Feb 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8717648CDC0001LW registered 28 Aug 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08717648138447 listed 19 Feb 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 762879 Restricted

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    10 Apr 2026
    Expires
    18 Apr 2028
    Reason
    Reduce scope

Timeline

4 dated events

  1. Listed FDA GUDID 08717648138447
  2. Certificate issued EUDAMED MDR 762879
  3. Registered EUDAMED 8717648CDC0001LW
  4. Certificate expires EUDAMED MDR 762879

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  • Withdrawn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
TREK™ Coronary Dilatation Catheter EUDAMED
Trek™ GUDID
Generic name
Coronary angioplasty balloon catheter, basic
Device name
Coronary Dilatation Catheter, RX, Semi-compliant
Model / Ref / Catalog
1012274-20
Primary DI / UDI-DI
08717648138447
Basic UDI-DI
8717648CDC0001LW
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
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 III
GUDID
Class II

Related devices

Category: Coronary angioplasty balloon catheter, basic

Other devices from Abbott Vascular

See all devices from Abbott Vascular →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)