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Google ECG app

by Fitbit LLC

Ref GA13098

Google ECG app (GA13098) is a device classified as Class IIa in the EU and Class II in the US made by Fitbit LLC, registered in EUDAMED on 20 May 2026 (Basic UDI-DI 081003885FB603R8), cleared under FDA 510(k) K200948 on 11 Sep 2020 and listed in FDA GUDID since 20 May 2026 (UDI-DI 00810028737815), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200948

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081003885FB603R8 Basic UDI-DI 00810028737815UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810028737815 UDI-DI Date20 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200948 Date11 Sep 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 081003885FB603R8 registered 20 May 2026 Active
  • FDA 510(k) K200948 decided 11 Sep 2020 Active
  • FDA GUDID UDI-DI 00810028737815 listed 20 May 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K200948
  2. Registered EUDAMED 081003885FB603R8
  3. Listed FDA GUDID 00810028737815

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / reference
GA13098
Primary DI / UDI-DI
00810028737815
Basic UDI-DI
081003885FB603R8
Direct marketing DI
00810028737815
510(k) Number
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 registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
US-MF-000007439
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE.

Other devices from Fitbit LLC

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Properties

  • Over-the-counter
Other properties (24, all answered No)