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Singapore HSA registration DE0018977

Sivantos Siemens Hearing Aids (ITE, Wireless, Digital)

Singapore flagSingapore·CLASS B·Sivantos GmbH·Registered February 15, 2017
Device classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration information
Registration Number
DE0018977
Registration Date
February 15, 2017
Change Notification Approval Date
October 10, 2017
Retention Due Date
February 14, 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
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)
S_ITE INT2 CLICK N-TAN R BG S_ITE INT2 CLICK N-TAN L BG S_ITE INT2 CLICK T3MOC R BG S_ITE INT2 CLICK T3MOC L BG Connexx 8.2.1
Model Identifier(s)
10936772 10936817 10938582 10938583 Connexx 8.2.1
About this record

Access comprehensive regulatory information for Sivantos Siemens Hearing Aids (ITE, 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 DE0018977 and owned by Sivantos GmbH. The device was registered on February 15, 2017.

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.

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