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MAC 5 Lite Resting ECG Analysis System

by GE Medical Systems Information Technologies, Inc. United States EUDAMEDGUDID

Ref 8855003-001Model MAC 5 A4 Product code DXHEMDN Z12050301

Regulatory status

as of 25 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278276087 UDI-DIDate9 Nov 2022ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number8406821BUG00244HA Basic UDI-DIDate15 Feb 2022RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2306-2026 FDA Class II initiated 21 Apr 2026

    Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
MAC 5 Lite Resting ECG Analysis System EUDAMED
Mac GUDID
Generic Name
Electrocardiograph, professional, multichannel
Device Name
MAC 5 A4 Resting ECG Analysis System
Model / Ref / Catalog
MAC 5 A4, 8855003-001, 5 LITE
Primary DI / UDI-DI
00195278276087
Basic UDI-DI
8406821BUG00244HA
Direct Marketing DI
00195278276087
510(k) Number
FDA Product Code
DXH, DQK, DPS
EMDN Code
Z12050301 General purpose electrocardiographs
GMDN Term
Electrocardiograph, professional, multichannel
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2920, 870.1425, 870.2340
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MAC 5 A4
8855003-001
GUDID
5 LITE
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Other devices from Ge Medical Systems Information Technologies, Inc.

See all devices from Ge Medical Systems Information Technologies, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Serial Number
  • Manufacturing Date
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED e605396d-65d7-47f1-a62b-2ea40b60ead9 61 fields · synced 22 Oct 2026
  • FDA UDI e67da0e4-e0ac-4cd5-b122-0f637b9ff060 35 fields · synced 30 May 2026