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Sivantos Rexton Hearing Aids (BTE, Digital) - HSA Registration DE0501401

Access comprehensive regulatory information for Sivantos Rexton Hearing Aids (BTE, 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 DE0501401 and owned by Sivantos GmbH. The device was registered on March 16, 2018.

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
DE0501401
Sivantos Rexton Hearing Aids (BTE, Digital)
HSA Registration Number: DE0501401
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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
DE0501401
Registration Date
March 16, 2018
Change Notification Approval Date
May 24, 2022
Retention Due Date
March 15, 2026
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)
HA RX MOSAIC M 10 E1 BG HA RX MOSAIC M 10 E1 DGT HA RX MOSAIC M 10 E1 GR - DGT HA RX MOSAIC M 10 E1 SLV - DGT HA RX MOSAIC M 10 E1 DBR - DGT HA EMERALD XS 30 E1 BG HA EMERALD XS 30 E1 DGT HA EMERALD XS 30 E1 BRN HA EMERALD XS 30 E1 GR HA EMERALD XS 30 E1 SLV HA EMERALD XS 20 E1 BG HA EMERALD XS 20 E1 DGT HA EMERALD XS 20 E1 BRN HA EMERALD XS 20 E1 GR HA EMERALD XS 20 E1 SLV HA MOSAIC S 10 E1 BG HA MOSAIC S 10 E1 BRN- DGT HA MOSAIC S 10 E1 DGT HA MOSAIC S 10 E1 GR- DGT HA MOSAIC S 10 E1 SLV- DGT HA MOSAIC P 10 E1 BG HA MOSAIC P 10 E1 DBR HA MOSAIC P 10 E1 GR HA MOSAIC HP 10 E1 BG HA MOSAIC HP 10 E1 DBR HA MOSAIC HP 10 E1 GR HA TARGA S 5A BG HA TARGA S 5A BRN - DGT HA TARGA S 5A GR - DGT HA EMERALD XS 80 8C BG HA EMERALD XS 80 8C DBR HA EMERALD XS 80 8C DGT HA EMERALD XS 80 8C GNT HA EMERALD XS 80 8C GR HA EMERALD XS 80 8C PRL HA EMERALD XS 80 8C SB HA EMERALD XS 80 8C SLV HA EMERALD XS 60 8C BG HA EMERALD XS 60 8C DBR HA EMERALD XS 60 8C DGT HA EMERALD XS 60 8C GNT HA EMERALD XS 60 8C GR HA EMERALD XS 60 8C PRL HA EMERALD XS 60 8C SB HA EMERALD XS 60 8C SLV HA EMERALD XS 40 8C BG HA EMERALD XS 40 8C DBR HA EMERALD XS 40 8C DGT HA EMERALD XS 40 8C GNT HA EMERALD XS 40 8C GR HA EMERALD XS 40 8C PRL HA EMERALD XS 40 8C SB HA EMERALD XS 40 8C SLV HA EMERALD XS 60 8C DBR HA EMERALD S 10 E1 BG HA EMERALD S 10 E1 DGT HA EMERALD S 10 E1 BRN HA EMERALD S 10 E1 GR HA EMERALD S 10 E1 SLV HA EMERALD XS 30 8C BG HA EMERALD XS 30 8C DBR HA EMERALD XS 30 8C PRL HA EMERALD XS 30 8C SB HA EMERALD XS 30 8C SLV HA EMERALD XS 30 8C GNT HA EMERALD XS 30 8C GR HA EMERALD XS 30 8C DGT HA EMERALD XS 20 8C BG HA EMERALD XS 20 8C DBR HA EMERALD XS 20 8C PRL HA EMERALD XS 20 8C SB HA EMERALD XS 20 8C SLV HA EMERALD XS 20 8C GNT HA EMERALD XS 20 8C GR HA EMERALD XS 20 8C DGT Application; Fit2go App v3.0.1.798 Connexx 8.5.10.82 Connexx 9.0.5 Connexx 9.2.5 Rexton App v2.1.1 Smart Remote app v2.40
Model Identifier(s)
10947923 10947925 10947927 10947929 10947932 10949078 10949079 10949080 10949081 10949082 10949083 10949084 10949085 10949086 10949087 10950394 10950395 10950396 10950397 10950398 10951341 10951349 10951351 10951740 10951741 10951742 10953080 10953082 10953083 10954286 10958567 10958568 10958569 10958570 10958571 10958572 10958573 10958574 10958575 10958576 10958577 10958578 10958579 10958580 10958581 10958582 10958583 10958584 10958585 10958586 10958587 10958588 10958589 10960575 10965320 10965321 10965322 10965323 10965324 10967268 10967269 10967270 10967271 10967272 10967273 10967274 10967275 10967276 10967277 10967278 10967279 10967280 10967281 10967282 10967283 Application; Fit2go App v3.0.1.798 Connexx 8.5.10.82 Connexx 9.0.5 Connexx 9.2.5 Rexton App v2.1.1 Smart Remote app v2.40