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Sivantos Rexton Hearing Aids (ITE, Digital) - HSA Registration DE0019396

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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CLASS B
DE0019396
Sivantos Rexton Hearing Aids (ITE, Digital)
HSA Registration Number: DE0019396
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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.

Device 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 Owner
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