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Garmin ECG App

by Garmin International, Inc. 2 variants

Ref Watch ECG App Component

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

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221774↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0860009117709SS Basic UDI-DI 00860009117716UDI-DIDate21 Oct 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00860009117716 UDI-DI Date24 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK221774 Date12 Jan 2023IssuedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Generic Name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / Reference
Watch ECG App Component EUDAMED
1.x GUDID
Primary DI / UDI-DI
00860009117716
Basic UDI-DI
0860009117709SS
Direct Marketing DI
00860009117716
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
Watch 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.

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