Skip to content

TactiSys™ PN-004400

by St. Jude Medical, Inc.

Ref PN-004400

TactiSys™ PN-004400 is a device classified as Class IIb in the EU and Class III in the US made by St. Jude Medical, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 5414734ABC00196N) and listed in FDA GUDID since 3 Nov 2014 (UDI-DI 07640157990194), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734ABC00196N Basic UDI-DI 07640157990194UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640157990194 UDI-DI Date3 Nov 2014ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5414734ABC00196N registered 24 Aug 2026 Active
  • FDA GUDID UDI-DI 07640157990194 listed 3 Nov 2014 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640157990194
  2. Registered EUDAMED 5414734ABC00196N

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TactiSys™
Generic name
Cardiac mapping system computer
Device name
TactiSys System
Model / Ref / Catalog
PN-004400
Primary DI / UDI-DI
07640157990194
Basic UDI-DI
5414734ABC00196N
FDA product code
OAE
EMDN code
Z12059011 Cardiac ablation equipment
GMDN term
Cardiac mapping system computer
Device class
Class IIb EUDAMED
Class III GUDID
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 IIb
GUDID
Class III

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardiac mapping system computer

Similar devices in this category

Other devices filed under CARDIAC ABLATION EQUIPMENT.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)