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Withings® WSM02

by Withings SA

Ref WSM02

Withings® WSM02 is a device classified as Class IIa in the EU and Class II in the US made by Withings SA, registered in EUDAMED on 11 May 2026 (Basic UDI-DI B-03700546706394) and listed in FDA GUDID since 3 Oct 2024 (UDI-DI 03700546706394), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03700546706394 Basic UDI-DI 03700546706394UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03700546706394 UDI-DI Date3 Oct 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-03700546706394 registered 11 May 2026 Active
  • FDA GUDID UDI-DI 03700546706394 listed 3 Oct 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03700546706394
  2. Registered EUDAMED B-03700546706394

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Withings Sleep Apnea Detector EUDAMED
Withings® GUDID
Generic name
Home-use sleep apnoea recording system
Model / reference
WSM02
Primary DI / UDI-DI
03700546706394 EUDAMED
03700546708497 GUDID
Basic UDI-DI
B-03700546706394
FDA product code
MNR
EMDN code
V9099 Various devices not included in other classes - other
GMDN term
Home-use sleep apnoea recording system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.2375
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
03700546706394
GUDID
03700546708497
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 03700546706394; FDA GUDID lists 03700546708497), so their flags are not compared. 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.

Related devices

Category: Home-use sleep apnoea recording system

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER.

Other devices from Withings SA

See all devices from Withings SA →

Properties

  • Measuring function
  • Prescription use
  • Serial number
Other properties (20, all answered No)