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Smart ECG K379

by Microport Crm SRL

Ref K379Model Smart ECG

Smart ECG K379 is a device classified as Class IIa in the EU and Class III in the US made by Microport Crm SRL, registered in EUDAMED on 27 May 2026 (Basic UDI-DI 8031527SMARTECG00000001V8), approved under FDA PMA P980049 on 15 Sep 1999 and listed in FDA GUDID since 14 Oct 2021 (UDI-DI 08031527017334), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

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

CE MDR PMA

Valid until

No date given

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

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

PMA P980049

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8031527SMARTECG00000001V8 Basic UDI-DI 08031527017334UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08031527017334 UDI-DI Date14 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP980049 Date15 Sep 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8031527SMARTECG00000001V8 registered 27 May 2026 Active
  • FDA PMA P980049 decided 15 Sep 1999 Active
  • FDA GUDID UDI-DI 08031527017334 listed 14 Oct 2021 Listed

Recalls

4 recalls · FDA

    • Terminated Z-3232-2017 FDA Class II initiated 24 Jul 2017

    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

  • 3 recalls, same reason

    • Terminated Z-3231-2017 FDA Class II initiated 24 Jul 2017
    • Terminated Z-3229-2017 FDA Class II initiated 24 Jul 2017
    • Terminated Z-3228-2017 FDA Class II initiated 24 Jul 2017

    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

Timeline

7 dated events

  1. Approved FDA PMA P980049
  2. Recall initiated FDA recalls Z-3232-2017
  3. Recall initiated FDA recalls Z-3231-2017
  4. Recall initiated FDA recalls Z-3229-2017
  5. Recall initiated FDA recalls Z-3228-2017
  6. Listed FDA GUDID 08031527017334
  7. Registered EUDAMED 8031527SMARTECG00000001V8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Smart ECG
Generic name
Electrocardiographic ambulatory recorder
Model / Ref / Catalog
K379, Smart ECG
Primary DI / UDI-DI
08031527017334
Basic UDI-DI
8031527SMARTECG00000001V8
Direct marketing DI
08031527017334
PMA number
FDA product code
MRM
EMDN code
Z12050403 ECG holter recorders
GMDN term
Electrocardiographic ambulatory recorder
Device class
Class IIa EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class III

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electrocardiographic ambulatory recorder

Cleared under the same submission (P980049)

and 8 more cleared under P980049

Similar devices in this category

Other devices filed under ECG HOLTER RECORDERS.

Other devices from Microport Crm SRL

See all devices from Microport Crm SRL →

Properties

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