SIVANTOS PTE LTD

Reg #: 3003426343 · FEI: 3003426343 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

Registration Details

Registration Name: SIVANTOS PTE LTD
Registration Number: 3003426343
FEI Number: 3003426343
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 18 TAI SENG STREET, #08-08
City: Singapore South East
Country: SG

Regulatory Submissions

510(k) Number: K233464

Owner / Operator

Firm Name: WS Audiology USA, Inc.
Operator Number: 9050836
Address: 101 Wood Avenue South, 7th Floor
City: Iselin
State: NJ
Postal Code: 08830
Country: US
Correspondent: Isabel - Restivo

US Agent

Business Name: WS Audiology USA, Inc.
Contact Name: Isabel Restivo
Address: 101 Wood Avenue South, 7th Floor
City: Iselin
State: NJ
ZIP: 08830
Country: US
Email: [email protected]
Phone: 551 5799581

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	Class 2	Ear, Nose, Throat	No	2011-07-12
Self-Fitting Air-Conduction Hearing Aid, Over The Counter	QUH	Class 2	Ear, Nose, Throat	No	2024-03-05
Self-Fitting Air-Conduction Hearing Aid, Prescription	QDD	Class 2	Ear, Nose, Throat	No	2024-03-05
Masker, Tinnitus	KLW	Class 2	Ear, Nose, Throat	No	2013-07-11
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	Class 2	Ear, Nose, Throat	No	2025-12-23

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 CROS Rexton Inox Signia AX CROS AX Signia Ace Insio Charge&Go Rexton Accord

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility