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EnSite™ EE3000

by St. Jude Medical, Inc.

Ref EE3000

EnSite™ EE3000 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-05415067014573), cleared under FDA 510(k) K201181 on 26 Jun 2020 (1 earlier submission) and listed in FDA GUDID since 24 May 2016 (UDI-DI 05415067014573), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201181

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05415067014573 Basic UDI-DI 05415067014573UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201181 Date26 Jun 2020DecidedStatusActive
United StatesGUDID listing GUDID Number05415067014573 UDI-DI Date24 May 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05415067014573 registered 28 Aug 2026 Active
  • FDA 510(k) K201181 decided 26 Jun 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05415067014573 listed 24 May 2016 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K141050
  2. Listed FDA GUDID 05415067014573
  3. Cleared FDA 510(k) K201181
  4. Registered EUDAMED B-05415067014573

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
EnSite™
Generic name
Cardiac mapping system
Device name
EnSite Velocity/Precision
Model / Ref / Catalog
EE3000
Primary DI / UDI-DI
05415067014573
Basic UDI-DI
B-05415067014573
510(k) Number
FDA product code
DQK
EMDN code
Z12059080 Various instruments for cardiology and cardiac surgery - hardware accessories
GMDN term
Cardiac mapping system
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

Cleared under the same submission (K141050)

and 8 more cleared under K141050

Cleared under the same submission (K201181)

and 8 more cleared under K201181

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
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)