Withings
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000009505 FEI 3008820594
Withings is a medical device manufacturer based in France, with 7 devices listed in FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.
- Devices
- 7
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 6
- EUDAMED 1
- Device classes
- FDA Class II 6
- EU Class IIa 1
- Top EMDN categories
- Identifiers
- EUDAMED SRN FR-MF-000009505
- FDA FEI 3008820594
- DUNS 260119720
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA establishment
What Withings makes
Withings manufactures reusable device sterilization and disinfection containers, alongside a range of medical monitoring equipment. Their product portfolio includes blood pressure monitors, infrared thermometers, body composition scales, and sleep apnea detection systems, as well as ECG display applications and companion software for health monitoring.
The company is based in France, and its devices are categorized as Class II and Class IIa medical equipment. These products are listed in the FDA 510(k) database and the EUDAMED registry.
Catalogue
Withings Blood Pressure Monitor Ref K110872
Regimes: 510(k) Registry: 510(k)Withings ECG App Ref K240795
Regimes: 510(k) Registry: 510(k)Withings Blood Presure Monitor Ref K133125
Regimes: 510(k) Registry: 510(k)Withings Sleep Rx Ref K231667
Regimes: 510(k) Registry: 510(k)Withings Thermo (Model SCT01) Ref K160544
Regimes: 510(k) Registry: 510(k)Withings Scan Monitor 2.0 Ref K230812
Regimes: 510(k) Registry: 510(k)Withings Body Comp Ref WBS12-White-All-Inter
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000009505
- FDA FEI number
- 3008820594
- DUNS number
- 260119720
- 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
- Website
- www.withings.com
- Phone
- +33141460460
- PRRC contact
- Xavier Debreuil
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 22 Dec 2027
ENTE CERTIFICAZIONE MACCHINE SRL 1282 1 certificate
- ECM22MDR001 Active
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
Quality management system EU MDR
- Issued
- 24 Aug 2026
- Expires
- 22 Dec 2027
- Valid from
- 31 Aug 2026
- Reason
- Add device or group
FDA establishments
- Withings SA FR
Frequently asked questions
How many devices does Withings have in the registry?
The registry currently lists 7 devices for Withings. Devices recorded under merged duplicate company entries are counted once.
Which registries list Withings's devices?
Among its 7 most recently registered devices, Withings has devices listed in EUDAMED (1 device) and FDA 510(k) (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Withings's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Withings's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Withings?
EUDAMED lists 2 certificates for Withings (quality management system) under MDR. The most recent was issued on 24 Aug 2026.
What are the newest devices from Withings in the registry?
The most recently registered devices listed for Withings include WITHINGS BLOOD PRESSURE MONITOR, Withings ECG App, WITHINGS BLOOD PRESURE MONITOR and Withings Sleep Rx.
Which FDA establishments are linked to Withings?
1 FDA establishment is linked to Withings in the registry; they are listed on the company page.