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Hi-Torque Command 2078172

by Abbott Vascular

Ref 2078172

Hi-Torque Command 2078172 is a device classified as Class IIa in the EU and Class II in the US made by Abbott Vascular, registered in EUDAMED on 21 Sep 2026 (Basic UDI-DI 8717648PGW000447) and listed in FDA GUDID since 25 Mar 2016 (UDI-DI 08717648176654), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8717648PGW000447 Basic UDI-DI 08717648176654UDI-DIDate21 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717648176654 UDI-DI Date25 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8717648PGW000447 registered 21 Sep 2026 Active
  • FDA GUDID UDI-DI 08717648176654 listed 25 Mar 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08717648176654
  2. Registered EUDAMED 8717648PGW000447

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  • Withdrawn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
Hi-Torque Command™ Guide Wire with Hydrophilic Coating EUDAMED
Hi-Torque Command GUDID
Generic name
Peripheral vascular guidewire, manual
Device name
Peripheral Guide Wire, SS/NiTi Core .014
Model / Ref / Catalog
2078172
Primary DI / UDI-DI
08717648176654
Basic UDI-DI
8717648PGW000447
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

Related devices

Category: Peripheral vascular guidewire, manual

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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)