FDA.reportPublic FDA data

SIVANTOS PTE LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30034263433003426343SIVANTOS PTE LTD1N2026-01-0118 TAI SENG STREET #08-08 Singapore South East SG 539775

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
207821501166627K233464WSA Self-Fitting Hearing Aid Gen 2QUH2024-02-09
207821526593874K220403Vibe SF Self-Fitting Hearing AidQDD2022-08-12
207821646111131K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)KLW2001-06-01
207821484437819
207821107435351
207821730328077

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KLW22001-06-01
QUH12024-02-09
QDD12022-08-12