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AM12Q 9293-062-50

by Mortara Instrument, Inc.

Part of a family of 9 devices: see the family page

Ref 9293-062-50Model 901095

AM12Q 9293-062-50 is a device classified as Class I in the EU and Class II in the US made by Mortara Instrument, Inc., registered in EUDAMED on 10 Jun 2026 (Basic UDI-DI 0732094GMN901095CPW), cleared under FDA 510(k) K152944 on 6 Jan 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345029697), active as of 25 Oct 2026. 5 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152944

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901095CPW Basic UDI-DI 00812345029697UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812345029697 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK152944 Date6 Jan 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0732094GMN901095CPW registered 10 Jun 2026 Active
  • FDA 510(k) K152944 decided 6 Jan 2016 Active
  • FDA GUDID UDI-DI 00812345029697 listed 24 Sep 2016 Listed

Recalls

5 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0321-2025 FDA Class II initiated 11 Oct 2024
    • Ongoing Z-0325-2025 FDA Class II initiated 11 Oct 2024

    There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

  • 2 recalls, same reason

    • Ongoing Z-0706-2024 FDA Class II initiated 8 Dec 2023
    • Ongoing Z-0705-2024 FDA Class II initiated 8 Dec 2023

    Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

    • Terminated Z-1817-2020 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

8 dated events

  1. Cleared FDA 510(k) K152944
  2. Listed FDA GUDID 00812345029697
  3. Recall initiated FDA recalls Z-1817-2020
  4. Recall initiated FDA recalls Z-0706-2024
  5. Recall initiated FDA recalls Z-0705-2024
  6. Recall initiated FDA recalls Z-0321-2025
  7. Recall initiated FDA recalls Z-0325-2025
  8. Registered EUDAMED 0732094GMN901095CPW

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
AM12Q
Generic name
Electrocardiographic lead set, reusable
Model / reference
9293-062-50, 901095
Primary DI / UDI-DI
00812345029697
Basic UDI-DI
0732094GMN901095CPW
510(k) Number
FDA product code
DPS
EMDN code
Z12050380 Electrocardiographs - hardware accessories
GMDN term
Electrocardiographic lead set, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2340
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrocardiographic lead set, reusable

Cleared under the same submission (K152944)

and 8 more cleared under K152944

Similar devices in this category

Other devices filed under ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES.

Other devices from Mortara Instrument, Inc.

See all devices from Mortara Instrument, Inc. →

Properties

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