Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003426343

FEI Number

3003426343

Entity Name

SIVANTOS PTE LTD

City/State/Country

Singapore South East, SG

Establishment Address

18 TAI SENG STREET, #08-08, Singapore South East 539775, SG

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

WS Audiology USA, Inc. (Owner Number: 9050836)

Owner / Operator Contact Address

101 Wood Avenue South, 7th Floor, Iselin, NJ 08830, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011366

PMA Number

N/A

All Registered Proprietary Names

Pure 312 AX CONNEXX Intuis 4 Motion Charge&Go Signia Pure Rexton CROS Signia Intuis Signia Silk Signia Active IX Signia IX Rexton M-Core Signia Styletto Rexton Reach Signia Active Pure Charge&Go Signia Intuis 3 Signia Insio Silk Charge&Go Signia Active Pro ALLURE Styletto IX Signia Motion Rexton Styletto AX Insio IX Signia Intuis Rexton CROS Signia Insio Signia Silk Signia CROS Rexton Inox Intuis 4 Signia AX CROS AX Intuis 3 Signia Ace Insio Charge&Go Signia Pure Rexton Accord Signia Motion Signia Styletto Motion Charge&Go Pure Charge&Go Signia IX Styletto AX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2011-07-12
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2024-03-05
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2024-03-05
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2013-07-11

Official Correspondent

Isabel Restivo

US Agent Details

Isabel Restivo Business: WS Audiology USA, Inc. Email: isabel.restivo@wsa.com Phone: (551) 5799581

Related Public Records

Same Entity

WS Audiology USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3019918054	WS Audiology Mexico S.A. de C.V.	Tijuana Baja California, MX
2430101	WS Audiology USA, Inc.	Hauppauge, NY, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003426343. Last updated year: 2026. Please use registration number 3003426343 when referencing this establishment in official correspondence.