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EnSite™ H00002

by St. Jude Medical, Inc.

Part of a family of 27 devices: see the family page

Ref H00002

EnSite™ H00002 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 5414734DMC0028CR), cleared under FDA 510(k) K201181 on 26 Jun 2020 (1 earlier submission) and listed in FDA GUDID since 17 Dec 2019 (UDI-DI 05415067000026), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201181

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMC0028CR Basic UDI-DI 05415067000026UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201181 Date26 Jun 2020DecidedStatusActive
United StatesGUDID listing GUDID Number05415067000026 UDI-DI Date17 Dec 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734DMC0028CR registered 28 Aug 2026 Active
  • FDA 510(k) K201181 decided 26 Jun 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05415067000026 listed 17 Dec 2019 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K130594
  2. Listed FDA GUDID 05415067000026
  3. Cleared FDA 510(k) K201181
  4. Registered EUDAMED 5414734DMC0028CR

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  • Withdrawn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
Electrical-only medical device connection cable, reusable
Device name
EnSite Velocity/Precision Accessories
Model / Ref / Catalog
H00002
Primary DI / UDI-DI
05415067000026
Basic UDI-DI
5414734DMC0028CR
510(k) Number
FDA product code
DQK
EMDN code
Z12059002 Cardiac mapping equipment
GMDN term
Electrical-only medical device connection cable, reusable
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: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K130594)

and 2 more cleared under K130594

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

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)