Data / Medical devices / Singapore / Sivantos Pte Ltd

Sivantos Pte Ltd: FDA-registered device maker in Singapore South East, Singapore, 3 510(k) clearances

Name: Sivantos Pte Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sivantos Pte Ltd is registered with the FDA (registration 3003426343) in Singapore South East, Singapore. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 9, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Sivantos Pte Ltd

FDA registration number: 3003426343
Address: 18 Tai Seng Street #08-08, Singapore South East, Singapore, 539775
Owner or operator: WS Audiology USA, Inc. (9050836)
Roles: Manufacturer, Specification developer
First device listed: July 12, 2011
Registered through: 2026
Brand names listed: ALLURE, CONNEXX, CROS AX, Evoke, Insio Charge&Go, Insio IX, Intuis 3, Intuis 4 and more

Devices it lists

Device	Product code	Class	Role	Source
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2	Manufacturer, Specification developer	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Manufacturer	accessdata.fda.gov
Masker, Tinnitus	KLW	2	Manufacturer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Over The Counter	QUH	2	Manufacturer, Specification developer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Prescription	QDD	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 9, 2024	K233464	WSA Self-Fitting Hearing Aid Gen 2	QUH	Substantially Equivalent	Wsaud A/S	accessdata.fda.gov
August 12, 2022	K220403	Vibe SF Self-Fitting Hearing Aid	QDD	Substantially Equivalent	Wsaud A/S	accessdata.fda.gov
June 1, 2001	K011366	CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)	KLW	Substantially Equivalent	Siemens Hearing Instruments, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.