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Eli 380 ELI380-AAS21

by Mortara Instrument, Inc.

Ref ELI380-AAS21Model 901133

Eli 380 ELI380-AAS21 is a device classified as Class IIa in the EU and Class II in the US made by Mortara Instrument, Inc., registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI B-00812345026436), cleared under FDA 510(k) K142105 on 5 Sep 2014 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345026436), 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 MDD 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) K142105

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/MDD EUDAMED NumberB-00812345026436 Basic UDI-DI 00812345026436UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812345026436 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK142105 Date5 Sep 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00812345026436 registered 13 Oct 2026 Active
  • FDA 510(k) K142105 decided 5 Sep 2014 Active
  • FDA GUDID UDI-DI 00812345026436 listed 24 Sep 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-1013-2023 FDA Class II initiated 31 Oct 2022

    One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

    • Terminated Z-1483-2021 FDA Class II initiated 31 Mar 2021

    Devices do not meet IEC 60601-2-27 requirements as labeled.

    • Terminated Z-1796-2015 FDA Class II initiated 29 May 2015

    Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demographics for a different patient when the record is transmitted to a records management system.

Timeline

6 dated events

  1. Cleared FDA 510(k) K142105
  2. Recall initiated FDA recalls Z-1796-2015
  3. Listed FDA GUDID 00812345026436
  4. Recall initiated FDA recalls Z-1483-2021
  5. Recall initiated FDA recalls Z-1013-2023
  6. Registered EUDAMED B-00812345026436

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ELI 380 Electrocardiograph EUDAMED
Eli 380 GUDID
Generic name
Electrocardiograph, professional, multichannel
Model / reference
ELI380-AAS21, 901133
Primary DI / UDI-DI
00812345026436
Basic UDI-DI
B-00812345026436
510(k) Number
FDA product code
DPS
EMDN code
Z12050302 Advanced diagnosis electrocardiographs
GMDN term
Electrocardiograph, professional, multichannel
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.2340
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Electrocardiograph, professional, multichannel

Cleared under the same submission (K142105)

and 8 more cleared under K142105

Similar devices in this category

Other devices filed under ADVANCED DIAGNOSIS ELECTROCARDIOGRAPHS.

Other devices from Mortara Instrument, Inc.

See all devices from Mortara Instrument, Inc. →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (22, all answered No)