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ELI 150c ELI150c-AAA-AAGAX

by Mortara Instrument, Inc.

Ref ELI150C-AAA-AAGAXModel 901129

ELI 150c ELI150c-AAA-AAGAX 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 29 Oct 2026 (Basic UDI-DI B-00812345025392), cleared under FDA 510(k) K101115 on 18 Jun 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345025392), active as of 7 Nov 2026. One FDA recall is 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

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101115

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00812345025392 Basic UDI-DI 00812345025392UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812345025392 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK101115 Date18 Jun 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00812345025392 registered 29 Oct 2026 Active
  • FDA 510(k) K101115 decided 18 Jun 2010 Active
  • FDA GUDID UDI-DI 00812345025392 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1810-2020 FDA Class II initiated 18 Mar 2020

    Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

Timeline

4 dated events

  1. Cleared FDA 510(k) K101115
  2. Listed FDA GUDID 00812345025392
  3. Recall initiated FDA recalls Z-1810-2020
  4. Registered EUDAMED B-00812345025392

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  • Withdrawn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 150c Electrocardiograph EUDAMED
ELI 150c GUDID
Generic name
Electrocardiograph, professional, multichannel
Model / reference
ELI150c-AAA-AAGAX, 901129
Primary DI / UDI-DI
00812345025392
Basic UDI-DI
B-00812345025392
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 (K101115)

and 8 more cleared under K101115

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)