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H701805

by St. Jude Medical, Inc.

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

Ref H701805

H701805 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 and listed in FDA GUDID since 22 Jul 2020 (UDI-DI 05415067018052), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201181

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734DMC0028CR Basic UDI-DI 05415067018052UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067018052 UDI-DI Date22 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201181 Date26 Jun 2020DecidedStatusActive

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
  • FDA GUDID UDI-DI 05415067018052 listed 22 Jul 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201181
  2. Listed FDA GUDID 05415067018052
  3. 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  • Withdrawn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

Generic name
Ink printer
Device name
EnSite Velocity/Precision Accessories
Model / Ref / Catalog
H701805
Primary DI / UDI-DI
05415067018052
Basic UDI-DI
5414734DMC0028CR
510(k) Number
FDA product code
DQK
EMDN code
Z12059002 Cardiac mapping equipment
GMDN term
Ink printer
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: Ink printer

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)