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Eli 280 ELI280-Aaa-Aafbd

by Mortara Instrument, Inc.

Ref ELI280-AAA-AAFBDModel 901132

Eli 280 ELI280-Aaa-Aafbd 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 6 Oct 2026 (Basic UDI-DI B-00812345026207), cleared under FDA 510(k) K122073 on 2 Aug 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345026207), active as of 24 Oct 2026. 2 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K122073

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-00812345026207 Basic UDI-DI 00812345026207UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812345026207 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK122073 Date2 Aug 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00812345026207 registered 6 Oct 2026 Active
  • FDA 510(k) K122073 decided 2 Aug 2012 Active
  • FDA GUDID UDI-DI 00812345026207 listed 24 Sep 2016 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0011-2022 FDA Class II initiated 3 Sep 2021

    The devices malfunction under specific operator workflows.

    • Terminated Z-1482-2021 FDA Class II initiated 31 Mar 2021

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K122073
  2. Listed FDA GUDID 00812345026207
  3. Recall initiated FDA recalls Z-1482-2021
  4. Recall initiated FDA recalls Z-0011-2022
  5. Registered EUDAMED B-00812345026207

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  • Withdrawn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 280 Electrocardiograph EUDAMED
Eli 280 GUDID
Generic name
Electrocardiograph, professional, multichannel
Model / reference
ELI280-AAA-AAFBD, 901132
Primary DI / UDI-DI
00812345026207
Basic UDI-DI
B-00812345026207
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 (K122073)

and 8 more cleared under K122073

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)