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Singapore HSA registration DE0510565

WSAUD SIGNIA IX ITE-ITC HEARING AIDS (WIRELESS, DIGITAL)

Singapore flagSingapore·CLASS B·WSAUD A/S·Registered April 07, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0510565
Registration Date
April 07, 2025
Retention Due Date
April 06, 2026
Product description
Hearing instruments are intended to improve the hearing of hearing impaired persons. Diagnosis and prescription of a hearing instrument must be performed by hearing health specialists, e.g. acousticians, audiologists or ENT doctors.
Product Owner
Name
WSAUD A/S
Short Name
WSAUD A/S
Address
Nymoellevej 6, 3540 Lynge, DENMARK
Registrant
Name
SIVANTOS PTE. LTD.
Address
18 TAI SENG STREET, #08-08, SINGAPORE 539775
Importer
Name
SIVANTOS PTE. LTD. WS Audiology SEA Pte Ltd
Address
18 TAI SENG STREET, 18 TAI SENG, #08-08, SINGAPORE 539775 18 TAI SENG STREET, 18 TAI SENG, #08-08, SINGAPORE 539775
Model information
Model Name(s)
INSIO 1IX ITC (thickness= 50µm - 100µm) INSIO 2IX ITC (thickness= 50µm - 100µm) INSIO 3IX ITC (thickness= 50µm - 100µm) INSIO 5IX ITC (thickness= 50µm - 100µm) INSIO 7IX ITC (thickness= 50µm - 100µm) INSIO 1IX ITE (thickness= 50µm - 100µm) INSIO 2IX ITE (thickness= 50µm - 100µm) INSIO 3IX ITE (thickness= 50µm - 100µm) INSIO 5IX ITE (thickness= 50µm - 100µm) INSIO 7IX ITE (thickness= 50µm - 100µm)
Model Identifier(s)
21039394 (100µm) 21039395 (100µm) 21039396 (100µm) 21039397 (100µm) 21039399 (100µm) 21039400 (100µm) 21039401 (100µm) 21039402 (100µm) 21039403 (100µm) 21039404 (100µm)
About this record

Access comprehensive regulatory information for WSAUD SIGNIA IX ITE-ITC HEARING AIDS (WIRELESS, DIGITAL) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510565 and owned by WSAUD A/S. The device was registered on April 07, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B