Skip to content

Patient Cable 9293-033-53

by Mortara Instrument, Inc.

Ref 9293-033-53Model 901011

Patient Cable 9293-033-53 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 0732094GMN901011ENE), cleared under FDA 510(k) K102206 on 18 Feb 2011 (4 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345024944), active as of 22 Oct 2026.

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

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K102206

+4 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901011ENE Basic UDI-DI 00812345024944UDI-DIDate10 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812345024944 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK102206 Date18 Feb 2011DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0732094GMN901011ENE registered 10 Jun 2026 Active
  • FDA 510(k) K102206 decided 18 Feb 2011 Active· +4 more in the status table
  • FDA GUDID UDI-DI 00812345024944 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1810-2020 FDA Class II initiated 18 Mar 2020 on shared 510(k) K092663

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

8 dated events

  1. Cleared FDA 510(k) K022618
  2. Cleared FDA 510(k) K092663
  3. Cleared FDA 510(k) K101115
  4. Cleared FDA 510(k) K101403
  5. Cleared FDA 510(k) K102206
  6. Listed FDA GUDID 00812345024944
  7. Recall initiated FDA recalls Z-1810-2020
  8. Registered EUDAMED 0732094GMN901011ENE

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
WAM/AMXX Lead Set EUDAMED
Patient Cable GUDID
Generic name
Electrocardiographic lead set, reusable
Model / reference
9293-033-53, 901011
Primary DI / UDI-DI
00812345024944
Basic UDI-DI
0732094GMN901011ENE
510(k) Number
FDA product code
MHX
EMDN code
Z12050380 Electrocardiographs - hardware accessories
GMDN term
Electrocardiographic lead set, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1025
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 (K022618)

and 8 more cleared under K022618

Cleared under the same submission (K092663)

and 8 more cleared under K092663

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
  • Lot / batch number
Other properties (23, all answered No)