EnSite™ ENSITE-DWS-01: CE/MDD Class IIb

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDD EUDAMED	NumberB-05415067032171 Basic UDI-DI 05415067032171UDI-DI	Date1 Sep 2026Registered	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special	NumberK242016	Date9 Aug 2024Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK231415	Date10 Aug 2023Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK223094	Date27 Dec 2022Decided	StatusActive
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK221213	Date18 Aug 2022Decided	StatusActive
United States	GUDID listing GUDID	Number05415067032171 UDI-DI	Date6 Jan 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional	NumberK202066	Date25 Nov 2020Decided	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-05415067032171 — open Devices and search for it
AccessGUDID record UDI-DI 05415067032171
FDA 510(k) database 510(k) number K242016
FDA 510(k) database 510(k) number K231415
FDA 510(k) database 510(k) number K223094
FDA 510(k) database 510(k) number K221213
FDA 510(k) database 510(k) number K202066

Across registries

3 registries list this device

EUDAMED Basic UDI-DI B-05415067032171 registered 1 Sep 2026 Active
FDA 510(k) K242016 decided 9 Aug 2024 Active· +4 more in the status table
FDA GUDID UDI-DI 05415067032171 listed 6 Jan 2021 Listed

Timeline

7 dated events

25 Nov 2020 Cleared FDA 510(k) K202066
6 Jan 2021 Listed FDA GUDID 05415067032171
18 Aug 2022 Cleared FDA 510(k) K221213
27 Dec 2022 Cleared FDA 510(k) K223094
10 Aug 2023 Cleared FDA 510(k) K231415
9 Aug 2024 Cleared FDA 510(k) K242016
1 Sep 2026 Registered EUDAMED B-05415067032171

Coverage

2 jurisdictions

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Withdrawn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 X EP System
Model / Ref / Catalog: ENSITE-DWS-01

Primary DI / UDI-DI: 05415067032171
Basic UDI-DI: B-05415067032171
510(k) Number: K202066
K221213
K223094
K231415
K242016
FDA product code: DQK
EMDN code: Z12059082 Various instruments for cardiology and cardiac surgery - software 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

Field	EUDAMED	GUDID
Device class	EUDAMED 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.

Category: Cardiac mapping system

Cleared under the same submission (K202066)

and 8 more cleared under K202066

Cleared under the same submission (K221213)

and 8 more cleared under K221213

Similar devices

Also classified as Cardiac mapping system.

Rhythmia™ Mapping System M004RH12000 — Boston Scientific Class II
Affera™ Integrated Mapping System AFR-00016 — MEDTRONIC, INC. Class II
RHYTHMIA HDx™ M004RA61030 — Boston Scientific Class II
OptiMap™ Workstation FG0008 — Cortex, Inc. Class II
Cardiac Function Laboratory CFL-M Inca — Cd Leycom BV Class II

Similar devices in this category

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

Other devices from St. Jude Medical, Inc.

Amplatzer™ 9-PFO-030

Class III
3625

Class III
3630W

Class III
Quartet™ 1457Q

Class III

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

Properties

Measuring function
Prescription use
Serial number
Manufacturing date

Other properties (21, all answered No)