FDA.reportPublic FDA data

WITHINGS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30078364543007836454Withings Inc.1Y2026-01-01225 Franklin street Boston MA US 02110
30136892283013689228Withings HK Limited1N2026-01-01Unit A, 25F, Billion Plaza II 10 Cheung Yue Street, Cheung Sha Wan Hong-Kong HK 00000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2345061380648502K252474Withings BeamO (SCT02)DPS2025-11-10
2345061178107086K240102Blood Pressure Monitor (TMB-2287-B)DXN2024-04-29
2345062072636101K231667Withings Sleep RxMNR2024-09-06
2345062039422485K230812Withings Scan Monitor 2.0DPS2023-08-23
2345062016045330K223374Blood Pressure MonitorDXN2023-06-30
2345061443568989K201456Scan MonitorDPS2021-10-05
2345061488276748K160544Withings Thermo (Model SCT01)FLL2016-06-17
2345061636756408K133125WITHINGS BLOOD PRESURE MONITORDXN2014-03-24
2345061667863127K131395TRANSTEK BLOOD PRESSURE MONITORDXN2013-06-19
2345061902113695K110872WITHINGS BLOOD PRESSURE MONITORDXN2011-05-20
2345061571818549K051539TRICOT BLOOD PRESSURE CUFFDXQ2005-08-05
2345061497008371
2345061005280073
2345061042583006
2345061474057063
2345061509845183

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN52024-04-29
DPS32025-11-10
MNR12024-09-06
FLL12016-06-17
DXQ12005-08-05

PMN#

GUDID#

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