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WorkMate Claris™ H700154

by St. Jude Medical, Inc.

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

Ref H700154

WorkMate Claris™ H700154 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 (1 earlier submission) and listed in FDA GUDID since 6 Nov 2015 (UDI-DI 05415067001542), 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

+1 more

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 05415067001542UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK210392 Date11 Mar 2021DecidedStatusActive
United StatesGUDID listing GUDID Number05415067001542 UDI-DI Date6 Nov 2015ListedStatusListed 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· +1 more in the status table
  • FDA GUDID UDI-DI 05415067001542 listed 6 Nov 2015 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

7 dated events

  1. Cleared FDA 510(k) K132073
  2. Listed FDA GUDID 05415067001542
  3. Cleared FDA 510(k) K210392
  4. Recall initiated FDA recalls Z-1853-2021
  5. Recall initiated FDA recalls Z-1854-2021
  6. Recall initiated FDA recalls Z-1855-2021
  7. 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
H700154
Primary DI / UDI-DI
05415067001542
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 (K132073)

and 8 more cleared under K132073

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)