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H702499

by St. Jude Medical, Inc.

Ref H702499

H702499 is a device classified as Class IIb in the EU and Class II in the US made by St. Jude Medical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI B-05415067026149) and listed in FDA GUDID since 8 Dec 2016 (UDI-DI 05415067026149), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05415067026149 Basic UDI-DI 05415067026149UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067026149 UDI-DI Date8 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-05415067026149 registered 28 Aug 2026 Active
  • FDA GUDID UDI-DI 05415067026149 listed 8 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05415067026149
  2. Registered EUDAMED B-05415067026149

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  • Withdrawn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

Generic name
Cardiac mapping system application software
Device name
EnSite Velocity/Precision
Model / Ref / Catalog
H702499
Primary DI / UDI-DI
05415067026149
Basic UDI-DI
B-05415067026149
FDA product code
DQK
EMDN code
Z12059092 Various instruments for cardiology and cardiac surgery - medical device software
GMDN term
Cardiac mapping system application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Cardiac mapping system application software

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR CARDIOLOGY AND CARDIAC SURGERY.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)