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Change Healthcare Cardiology ECG Management 15.1.4

by Change Healthcare Canada Company

Ref 15.1.4

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-17540262110166 Basic UDI-DI 17540262110166UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17540262110166 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1682-2020 FDA Class II initiated 10 Feb 2020

    Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format

    • Terminated Z-0910-2015 FDA Class II initiated 19 Dec 2014

    An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Change Healthcare Cardiology ECG Management
Generic Name
Cardiac mapping system computer
Model / Reference
15.1.4
Primary DI / UDI-DI
17540262110166
Basic UDI-DI
B-17540262110166
510(k) Number
FDA Product Code
DQK
EMDN Code
Z12059009 ECG data management systems
GMDN Term
Cardiac mapping system computer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1425
Special Device Type
-1192
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K113515)

Show all (11)

Other devices from Change Healthcare Canada Company

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No