Skip to content

WorkMate Claris™ H701313

by St. Jude Medical, Inc.

Part of a family of 41 devices: see the family page

Ref H701313

WorkMate Claris™ H701313 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 1 Sep 2026 (Basic UDI-DI 5414734RCC0029G7), cleared under FDA 510(k) K210392 on 11 Mar 2021 and listed in FDA GUDID since 28 Mar 2016 (UDI-DI 05415067013132), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734RCC0029G7 Basic UDI-DI 05415067013132UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK210392 Date11 Mar 2021DecidedStatusActive
United StatesGUDID listing GUDID Number05415067013132 UDI-DI Date28 Mar 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734RCC0029G7 registered 1 Sep 2026 Active
  • FDA 510(k) K210392 decided 11 Mar 2021 Active
  • FDA GUDID UDI-DI 05415067013132 listed 28 Mar 2016 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. Listed FDA GUDID 05415067013132
  2. Cleared FDA 510(k) K210392
  3. Recall initiated FDA recalls Z-1853-2021
  4. Recall initiated FDA recalls Z-1854-2021
  5. Recall initiated FDA recalls Z-1855-2021
  6. Registered EUDAMED 5414734RCC0029G7

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
WorkMate Claris™
Generic name
Cardiac catheterization monitoring system
Device name
WorkMate Claris Accessories
Model / Ref / Catalog
H701313
Primary DI / UDI-DI
05415067013132
Basic UDI-DI
5414734RCC0029G7
510(k) Number
FDA product code
DQK
EMDN code
Z12050701 Complete cardiography systems
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 (K110085)

and 8 more cleared under K110085

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)