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Garmin ECG App

by Garmin International, Inc. 2 variants

Ref Smartphone ECG App Component

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0860009117709SS Basic UDI-DI 00860009117709UDI-DIDate21 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00860009117709 UDI-DI Date24 Jan 2023ListedStatusListed 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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / Reference
Smartphone ECG App Component EUDAMED
1.x GUDID
Primary DI / UDI-DI
00860009117709
Basic UDI-DI
0860009117709SS
Direct Marketing DI
00860009117709
FDA Product Code
QDA
EMDN Code
Z12050392 Electrocardiographs - medical device software
GMDN Term
Cardiopulmonary physiological parameter analysis software, professional-only
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.2345
Special Device Type
Software
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Smartphone ECG App Component
GUDID
1.x
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000037975
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Garmin International, Inc.

  • Garmin ECG App

    Class IIa

Properties

  • Measuring Function
  • Over-the-Counter
  • Lot / Batch Number

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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No