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Ep-4™ H700162

by St. Jude Medical, Inc.

Part of a family of 8 devices: see the family page

Ref H700162

Ep-4™ H700162 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 5414734CSC0030E9), cleared under FDA 510(k) K210392 on 11 Mar 2021 and listed in FDA GUDID since 3 Jan 2025 (UDI-DI 05415067001627), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

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 ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K210392

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734CSC0030E9 Basic UDI-DI 05415067001627UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067001627 UDI-DI Date3 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK210392 Date11 Mar 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734CSC0030E9 registered 28 Aug 2026 Active
  • FDA 510(k) K210392 decided 11 Mar 2021 Active
  • FDA GUDID UDI-DI 05415067001627 listed 3 Jan 2025 Listed

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1853-2021 FDA Class II initiated 5 May 2021
    • Terminated Z-1854-2021 FDA Class II initiated 5 May 2021
    • Terminated Z-1855-2021 FDA Class II initiated 5 May 2021

    Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

Timeline

6 dated events

  1. Cleared FDA 510(k) K210392
  2. Recall initiated FDA recalls Z-1853-2021
  3. Recall initiated FDA recalls Z-1854-2021
  4. Recall initiated FDA recalls Z-1855-2021
  5. Listed FDA GUDID 05415067001627
  6. Registered EUDAMED 5414734CSC0030E9

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
Ep-4™
Generic name
Cardiac catheterization monitoring system
Device name
EP-4 Accessories
Model / Ref / Catalog
H700162
Primary DI / UDI-DI
05415067001627
Basic UDI-DI
5414734CSC0030E9
510(k) Number
FDA product code
DQK
EMDN code
Z1205078001 Cardiac electrophysiology stimulators
GMDN term
Cardiac catheterization monitoring system
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 catheterization monitoring system

Cleared under the same submission (K210392)

and 8 more cleared under K210392

Similar devices in this category

Other devices filed under CARDIOGRAPHY INSTRUMENTS.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)