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Patient Cable 9293-017-51

by Mortara Instrument, Inc.

Ref 9293-017-51Model 901006

Patient Cable 9293-017-51 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 13 Jul 2026 (Basic UDI-DI 0732094GMN901006ENQ), cleared under FDA 510(k) K081800 on 24 Sep 2008 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00812345024807), active as of 24 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

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081800

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0732094GMN901006ENQ Basic UDI-DI 00812345024807UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00812345024807 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK081800 Date24 Sep 2008DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0732094GMN901006ENQ registered 13 Jul 2026 Active
  • FDA 510(k) K081800 decided 24 Sep 2008 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00812345024807 listed 24 Sep 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1812-2020 FDA Class II initiated 18 Mar 2020 on shared 510(k) K050896
    • Terminated Z-1813-2020 FDA Class II initiated 18 Mar 2020 on shared 510(k) K081800

    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

6 dated events

  1. Cleared FDA 510(k) K050896
  2. Cleared FDA 510(k) K081800
  3. Listed FDA GUDID 00812345024807
  4. Recall initiated FDA recalls Z-1812-2020
  5. Recall initiated FDA recalls Z-1813-2020
  6. Registered EUDAMED 0732094GMN901006ENQ

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
H12+ Patient Cable EUDAMED
Patient Cable GUDID
Generic name
Electrocardiographic lead set, reusable
Model / reference
9293-017-51, 901006
Primary DI / UDI-DI
00812345024807
Basic UDI-DI
0732094GMN901006ENQ
510(k) Number
FDA product code
DQA, DSH
EMDN code
Z12050480 Holter system instruments for cardiovascular parameters - hardware accessories
GMDN term
Electrocardiographic lead set, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2700, 870.2800
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 (K050896)

and 1 more cleared under K050896

Cleared under the same submission (K081800)

and 5 more cleared under K081800

Similar devices in this category

Other devices filed under HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - 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)