Singapore HSA registration DE0019396
Sivantos Rexton Hearing Aids (ITE, Digital)
Singapore·CLASS B·Sivantos GmbH·Registered July 10, 2017Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0019396
- Registration Date
- July 10, 2017
- Change Notification Approval Date
- April 04, 2018
- Retention Due Date
- July 09, 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. acousticians, audiologists or ENT doctors.
Product Owner
- Name
- Sivantos GmbH
- Short Name
- Sivantos GmbH
- Address
- Henri-Dunant-Str. 100, 91058 Erlangen, GERMANY
Registrant
- Address
- 18 TAI SENG STREET, #08-08, SINGAPORE 539775
Importer
- 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 INOX 5A T3MOC L BG S_ITE INOX 5A T3MOC R BG S_ITE INOX 5A N-TAN L BG S_ITE INOX 5A N-TAN R BG KMAT STERLING 10 E1 (CUS.IN) KMAT STERLING 5 (CUS.IN) S_ITE INOX CIC 10 E1 L BG S_ITE INOX CIC 10 E1 R BG S_ITE INOX ITC 10 E1 L BG S_ITE INOX ITC 10 E1 R BG Connexx 8.4.5 Fit-2-Go App v2.0 Smart Connect App v2.30 Smart Remote App v2.40
- Model Identifier(s)
- 10943517 10943518 10943523 10943524 10946846 10946848 10953014 10953017 10953018 10953019 Connexx 8.4.5 Fit-2-Go App v2.0 Smart Connect App v2.30 Smart Remote App v2.40
About this record
Access comprehensive regulatory information for Sivantos Rexton Hearing Aids (ITE, 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 DE0019396 and owned by Sivantos GmbH. The device was registered on July 10, 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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