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Fitbit LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000007439 FEI 3009253624

Fitbit LLC is a medical device manufacturer based in the United States, with 16 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa) as of 13 Nov 2026.

Devices
16
Registrations
EUDAMEDFDA
FDA recalls
0

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 11
  • EUDAMED 7
  • FDA 510(k) 5

A device listed in two registries counts in both.

Device classes
  • FDA Class II 10
  • EU Class IIa 6
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000007439
  • FDA FEI 3009253624
  • DUNS 829454672

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI
Authorised rep.
Emergo Europe B.V.NL

What Fitbit LLC makes

Fitbit LLC manufactures bioelectrical body composition analysers and cardiopulmonary physiological parameter analysis software, including devices such as the Google ECG app, Google Irregular Rhythm Notifications, Aria 2 Wi-Fi Smart Scale, Body Temperature Software, and Loss of Pulse Detection.

The company's portfolio includes Class II and Class IIa devices listed in eudamed, fda_510k, and fda_udi registries, and Fitbit LLC is based in the US.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Fitbit ECG App Ref K200948

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Breathing Emergency Detection Ref GA11010

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Google ECG app Ref GA13098

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Google Irregular Rhythm Notifications Ref GA13099

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Aria 2 Wi-Fi Smart Scale FB202

    Listed Registry: GUDID Class:II

  • Aria FB201B

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Aria 2 Wi-Fi Smart Scale FB202

    Listed Registry: GUDID Class:II

  • Fitbit Irregular Rhythm Notifications FB604

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:II

  • Aria FB201W

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Aria FB201B2

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Body Temperature Software (BTS) Ref K243778

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aria Wifi Smart Scale Ref K133872

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Fitbit Irregular Rhythm Notifications Ref K212372

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • Loss of Pulse Detection Ref FB612

    Active Regimes: CE MDR 510(k) Registry: EUDAMEDGUDID Class:IIa

  • Body Temperature Software Ref FB611

    Active Regimes: CE MDR De Novo Registry: EUDAMEDDe NovoGUDID Class:IIa

  • Fitbit ECG App Ref FB603

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

Rows 1-16 of 16

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000007439
FDA FEI number
3009253624
DUNS number
829454672
EUDAMED status
Active
EUDAMED registered name
Fitbit LLC
EUDAMED abbreviated name
Fitbit
Registered address
215, Fremont St., CA 94105, San Francisco, United States
Phone
United States: +1 877 623 4997 Canada: +1 877 623-4997 UK: +448000265911 Ireland: +35316917502
PRRC contact
Adam Vasquez(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 28 Nov 2031

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 121911 0004 Active Reissued

    Quality management system EU MDR

    Issued
    10 Sep 2026
    Expires
    28 Nov 2031
    Valid from
    29 Nov 2026

Frequently asked questions

How many devices does Fitbit LLC have in the registry?

The registry currently lists 16 devices for Fitbit LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Fitbit LLC's devices?

Among its 16 most recently registered devices, Fitbit LLC has devices listed in EUDAMED (7 devices), FDA 510(k) (5 devices) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Fitbit LLC's devices fall under?

Among its 16 most recently registered devices, the classes recorded for Fitbit LLC's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Fitbit LLC?

EUDAMED lists 1 certificate for Fitbit LLC (quality management system) under MDR. The most recent was issued on 10 Sep 2026.

What are the newest devices from Fitbit LLC in the registry?

The most recently registered devices listed for Fitbit LLC include Fitbit ECG App, Breathing Emergency Detection, Google ECG app and Google Irregular Rhythm Notifications.

Generated automatically from registry data and not verified by a human reviewer.