FDA.reportPublic FDA data

SIVANTOS PTE LTD

Matched from indexed company URL: SIVANTOS, INC.

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
21351293003291347SIVANTOS, INC.1N2020-04-25ATRIA Corporate Center, Suite W125 3033 Campus Drive Plymouth MN US 55441
22178092217809SIVANTOS, INC.1Y2020-04-2510 Constitution Ave PISCATAWAY NJ US 08854

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05711781000003Siemens - Siemens UNITY 3 INSERTS17325626600consumerrelations@sivantos.com
05711781000004Siemens - Siemens UNITY 3 REM PROBE ASSEMBLY17325626600consumerrelations@sivantos.com
05711781000009Siemens - Siemens UNITY 3 CLIENT RESPONSE17325626600consumerrelations@sivantos.com
05711781000010Siemens - Siemens UNITY 3 DD4517325626600consumerrelations@sivantos.com
05711781000012Siemens - Siemens UNITY 3 3A INSERTS17325626600consumerrelations@sivantos.com
05711781000017Siemens - Siemens UNITY 3 SOUNDBOOTH CABLE SET17325626600consumerrelations@sivantos.com
05711781000018Siemens - Siemens UNITY 3 EAR HANGER17325626600consumerrelations@sivantos.com
05711781000020Siemens - Siemens UNITY 3 DC ADAPTOR (AUD/REM)17325626600consumerrelations@sivantos.com

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
576741875591859K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)ETW2007-06-05
207821646111131K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)KLW2001-06-01
2270371646111131K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)KLW2001-06-01
2270371107435351
576741249418252
207821484437819
2270371484437819
207821107435351
207821730328077

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KLW32001-06-01
QUH12024-02-09
QDD12022-08-12
ETW12007-06-05

GUDID#