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EnSite™ SURF-ELEC-2PRS

by St. Jude Medical, Inc.

Ref SURF-ELEC-2PRS

EnSite™ SURF-ELEC-2PRS is a device classified as Class I 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 5414734DMS0040HX), cleared under FDA 510(k) K201181 on 26 Jun 2020 and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 05415067032300), active as of 24 Oct 2026.

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

CE MDR 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, self-declared

Class I: no certifier involved

510(k) K201181

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMS0040HX Basic UDI-DI 05415067032300UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067032300 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201181 Date26 Jun 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734DMS0040HX registered 28 Aug 2026 Active
  • FDA 510(k) K201181 decided 26 Jun 2020 Active
  • FDA GUDID UDI-DI 05415067032300 listed 22 Jul 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K201181
  2. Listed FDA GUDID 05415067032300
  3. Registered EUDAMED 5414734DMS0040HX

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EnSite™
Generic name
Cardiac mapping system reference patch
Device name
EnSite Velocity/Precision Surface Electrodes
Model / Ref / Catalog
SURF-ELEC-2PRS
Primary DI / UDI-DI
05415067032300
Basic UDI-DI
5414734DMS0040HX
510(k) Number
FDA product code
DQK
EMDN code
Z12059085 Various instruments for cardiology and cardiac surgery - consumables
GMDN term
Cardiac mapping system reference patch
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1425
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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 reference patch

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

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)