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EnSite Precision™ EN0020-P

by St. Jude Medical, Inc. 2 variants

Ref EN0020-P

EnSite Precision™ EN0020-P 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 31 Aug 2026 (Basic UDI-DI 5414734DMS0039JE), cleared under FDA 510(k) K201181 on 26 Jun 2020 and listed in FDA GUDID since 28 Feb 2022 (UDI-DI 05415067041715), active as of 25 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 25 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K201181

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMS0039JE Basic UDI-DI 05415067041715UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067041715 UDI-DI Date28 Feb 2022ListedStatusListed 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 5414734DMS0039JE registered 31 Aug 2026 Active
  • FDA 510(k) K201181 decided 26 Jun 2020 Active
  • FDA GUDID UDI-DI 05415067041715 listed 28 Feb 2022 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 05415067041715
  3. Registered EUDAMED 5414734DMS0039JE

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  • Withdrawn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 Precision™
Generic name
Cardiac mapping system reference patch
Device name
EnSite Velocity/Precision Surface Electrode Procedure Pack
Model / Ref / Catalog
EN0020-P
Primary DI / UDI-DI
05415067041715
Basic UDI-DI
5414734DMS0039JE
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
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
DISEASE_TREATMENT_PROCEDURES
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
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)