Skip to content

53401

by Medtronic, Inc.

Ref 53401

53401 is a device classified as Class IIb in the EU and Class II in the US made by Medtronic, Inc., registered in EUDAMED on 4 Sep 2026 (Basic UDI-DI B-00643169723177) and listed in FDA GUDID since 12 Mar 2017 (UDI-DI 00643169723177), active as of 22 Oct 2026.

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

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00643169723177 Basic UDI-DI 00643169723177UDI-DIDate4 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00643169723177 UDI-DI Date12 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00643169723177 registered 4 Sep 2026 Active
  • FDA GUDID UDI-DI 00643169723177 listed 12 Mar 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00643169723177
  2. Registered EUDAMED B-00643169723177

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
External pacemaker, epicardial pacing
Device name
Temporary External Pacemaker (TEP)
Model / reference
53401
Primary DI / UDI-DI
00643169723177 EUDAMED
00643169723160 GUDID
Basic UDI-DI
B-00643169723177
FDA product code
DTE
EMDN code
C020299 Cardiac temporary stimulation devices (with or without active substances) - other
GMDN term
External pacemaker, epicardial pacing
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.3600
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00643169723177
GUDID
00643169723160
Device classEUDAMED
Class IIb
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00643169723177; FDA GUDID lists 00643169723160), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb 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: External pacemaker, epicardial pacing

Similar devices in this category

Other devices filed under CARDIAC TEMPORARY STIMULATION DEVICES (WITH OR WITHOUT ACTIVE SUBSTANCES).

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)