Withings®

FDA UDI

Class II (US FDA UDI)

by Withings SA

Identity

Trade Name: Withings® FDA UDI
Generic Name: Electrocardiograph, home-use FDA UDI
Model / Reference: WBS08-Black FDA UDI

Identifiers

Primary DI / UDI-DI: 03700546708435 FDA UDI
FDA Product Code: PUH FDA UDI
DXH FDA UDI
DPS FDA UDI
GMDN Term: Electrocardiograph, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2770 FDA UDI
870.2920 FDA UDI
870.2340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bioelectrical body composition analyser Electrocardiograph, home-use

Withings® by Withings SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiograph, home-use.

ASSURE Wearable ECG — Kestra Medical Technologies, Inc. · Class II
AfibAlert / hom ecg+ — LOHMAN TECHNOLOGIES, LLC · Class II
QT ECG — QT Medical, Inc. · Class II
GEMS Mobile ECG — CardioComm Solutions, Inc · Class II
TelePatch Cardiac Monitor — MEDICOMP, INC. · Class II
KardiaMobile Card — AliveCor · Class II
System Cable — Kestra Medical Technologies, Inc. · Class II
Coala Heart Monitor US Rx — Coala-Life AB · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Withings SA

Sources (1)

FDA UDI f9301bd8-037d-43c6-ad18-b73ff00fd523 32 fields · synced Jun 8, 2026