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Withings SA

Active in EUDAMED

Registered as Withings in EUDAMED

Francefrom SRN EUDAMED SRN FR-MF-000009505

Part of Withings

Withings SA is a medical device manufacturer based in France, with 49 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class IIa; FDA Class II and I) and 2 FDA recalls as of 12 Nov 2026.

Devices
49
Registrations
EUDAMED
FDA recalls
21 ongoing

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 32
  • EUDAMED 26
  • FDA 510(k) 1

A device listed in two registries counts in both.

Device classes
  • EU Class IIa 25
  • FDA Class II 15
  • FDA Class I 9
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN FR-MF-000009505

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA recalls

What Withings SA makes

Withings SA manufactures bioelectrical body composition analysers, stand-on electronic floor scales, home-use electrocardiographs, reusable wearable multiple physiological parameter recorders, home-use sleep apnoea recording systems, and skin electrical conductance meters.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue49

Newest first, rows 1-49 of 49

Search and filter all 49 devices
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Rows 1-49 of 49

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
FR-MF-000009505
EU VAT number
FR 65 504 787 565
EUDAMED status
Active
EUDAMED registered name
Withings
Registered address
2, Maurice Hartmann, 92130, Issy-les-Moulineaux, France
Phone
+33141460460
PRRC contact
Xavier Debreuil(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 22 Dec 2027

EUDAMED certificates (2)

ENTE CERTIFICAZIONE MACCHINE SRL 1282 1 certificate

  • ECM22MDR001 Active Supplemented

    Quality management system EU MDR

    Issued
    23 Feb 2026
    Expires
    22 Dec 2027
    Reason
    Add device or group

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G15 108309 0001 Active Supplemented

    Quality management system EU MDR

    Issued
    24 Aug 2026
    Expires
    22 Dec 2027
    Valid from
    31 Aug 2026
    Reason
    Add device or group

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Withings SA, the earliest on 2018-06-11 and the most recent on 2022-12-19. By recorded status: 1 ongoing and 1 with another status. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 1
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2022

    • 19 Dec 2022 Z-1280-2023 Class II Ongoing A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician. Distribution: Nationwide distribution in the US. No foreign distribution. Submission number: K201456

  • 2018

    • 11 Jun 2018 Z-2829-2018 Class II Completed Device could not meet the requirements for systolic pressure Distribution: US Nationwide Distribution Submission number: K133125

Frequently asked questions

How many devices does Withings SA have in the registry?

The registry currently lists 49 devices for Withings SA. Devices recorded under merged duplicate company entries are counted once.

Which registries list Withings SA's devices?

Among its 49 most recently registered devices, Withings SA has devices listed in EUDAMED (26 devices), FDA 510(k) (1 device) and FDA GUDID (32 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Withings SA's devices fall under?

Among its 49 most recently registered devices, the classes recorded for Withings SA's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Withings SA?

FDA recall records list 2 recalls initiated by Withings SA, the most recent initiated on 19 Dec 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Withings SA?

EUDAMED lists 2 certificates for Withings SA (quality management system) under MDR. The most recent was issued on 24 Aug 2026.

What are the newest devices from Withings SA in the registry?

The most recently registered devices listed for Withings SA include BPM Core, Withings® WBS08-White, Withings® WBS05-Pastel Sand and Nokia WBS05-Black.

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