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Singapore HSA registration DE0505930

Sivantos hear.com horizon Hearing Aids (BTE, Digital, Wireless)

Singapore flagSingapore·CLASS B·Sivantos GmbH·Registered June 25, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0505930
Registration Date
June 25, 2021
Change Notification Approval Date
May 12, 2022
Retention Due Date
June 24, 2025
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. ENT doctors, audiologists or acousticians.
Product Owner
Name
Sivantos GmbH
Short Name
Sivantos GmbH
Address
Henri-Dunant-Str. 100, 91058 Erlangen, GERMANY
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)
horizon 7X RIC-R horizon 7X RIC-R horizon 7X RIC-R horizon 7X RIC-R horizon 3X RIC-R horizon 3X RIC-R horizon 3X RIC-R horizon 3X RIC-R horizon sDemo DX RIC-R horizon 5X RIC-R horizon 5X RIC-R horizon 5X RIC-R horizon 5X RIC-R horizon 7X RIC-S horizon 7X RIC-S horizon 7X RIC-S horizon 7X RIC-S horizon 7X RIC-S horizon 5X RIC-S horizon 5X RIC-S horizon 5X RIC-S horizon 5X RIC-S horizon 5X RIC-S horizon 3X RIC-S horizon 3X RIC-S horizon 3X RIC-S horizon 3X RIC-S horizon 3X RIC-S horizon sDemo DX RIC-S Connexx hear.com HORIZON myREMOTE
Model Identifier(s)
10973881 10973882 10973883 10973884 10973885 10973886 10973888 10973889 10973891 10981640 10981641 10981642 10981643 10993949 10993950 10993951 10993952 10993953 10993959 10993960 10993961 10993962 10993963 10993969 10993970 10993971 10993972 10993973 10993979 Connexx hear.com HORIZON myREMOTE
About this record

Access comprehensive regulatory information for Sivantos hear.com horizon Hearing Aids (BTE, Digital, Wireless) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505930 and owned by Sivantos GmbH. The device was registered on June 25, 2021.

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