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Sivantos Rexton Hearing Aids (ITE, Wireless, Digital) - HSA Registration DE0018978

Access comprehensive regulatory information for Sivantos Rexton 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 DE0018978 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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CLASS B
DE0018978
Sivantos Rexton Hearing Aids (ITE, Wireless, Digital)
HSA Registration Number: DE0018978
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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
DE0018978
Registration Date
February 15, 2017
Change Notification Approval Date
September 21, 2021
Retention Due Date
February 14, 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)
REXTON INOX CIC 80 6C REXTON INOX CIC 80 6C REXTON INOX CIC 60 6C REXTON INOX CIC 60 6C REXTON INOX CIC 40 6C REXTON INOX CIC 40 6C REXTON INOX ITC 10 REXTON INOX ITC 10 REXTON INOX ITC 5 REXTON INOX ITC 5 REXTON INOX CIC 10 REXTON INOX CIC 10 REXTON INOX CIC 5 REXTON INOX CIC 5 REXTON INOX SD 6C REXTON INOX SD 6C REXTON INOX CIC 30 E1 REXTON INOX CIC 20 E1 REXTON INOX CIC 30 E1 REXTON INOX CIC 20 E1 REXTON INOX CIC 80 8C REXTON INOX CIC 80 8C REXTON INOX CIC 80 8C REXTON INOX CIC 80 8C REXTON INOX CIC 60 8C REXTON INOX CIC 60 8C REXTON INOX CIC 40 8C REXTON INOX CIC 60 8C REXTON INOX CIC 40 8C REXTON INOX CIC 40 8C REXTON INOX CIC 40 8C REXTON INOX CIC 40 8C REXTON SMART DEMO INOX CIC 8C REXTON SMART DEMO INOX CIC 8C REXTON STERLING 80 8C REXTON STERLING 60 8C REXTON STERLING 80 8C REXTON STERLING 80 8C REXTON STERLING 60 8C REXTON STERLING 60 8C REXTON STERLING 60 8C REXTON STERLING 60 8C REXTON STERLING 40 8C REXTON STERLING 40 8C REXTON STERLING 40 8C REXTON STERLING 40 8C REXTON INOX CIC 30 8C REXTON INOX CIC 30 8C REXTON INOX CIC 30 8C REXTON INOX CIC 30 8C REXTON INOX CIC 20 8C REXTON INOX CIC 20 8C REXTON INOX CIC 20 8C REXTON INOX CIC 20 8C REXTON M-CORE IX-CIC 80 REXTON M-CORE IX-CIC 80 REXTON M-CORE IX-CIC 80 REXTON M-CORE IX-CIC 80 REXTON M-CORE IX-CIC 60 REXTON M-CORE IX-CIC 60 REXTON M-CORE IX-CIC 60 REXTON M-CORE IX-CIC 60 REXTON M-CORE IX-CIC SDEMO REXTON M-CORE IX-CIC 40 REXTON M-CORE IX-CIC 40 REXTON M-CORE IX-CIC 40 REXTON M-CORE IX-CIC 30 REXTON M-CORE IX-CIC 30 REXTON M-CORE IX-CIC 30 REXTON M-CORE IX-CIC 30 REXTON M-CORE IX-CIC 20 REXTON M-CORE IX-CIC 20 REXTON M-CORE IX-CIC 20 REXTON M-CORE IX-CIC 20 REXTON M-CORE IX-CIC SDEMO REXTON M-CORE IX-CIC SDEMO REXTON KMAT STERLING 30 8C (CUS.IN) REXTON KMAT STERLING 30 8C (CUS.IN) REXTON KMAT STERLING 30 8C (CUS.IN) REXTON KMAT STERLING 30 8C (CUS.IN) REXTON KMAT STERLING 20 8C (CUS.IN) REXTON KMAT STERLING 20 8C (CUS.IN) REXTON KMAT STERLING 20 8C (CUS.IN) REXTON KMAT STERLING 20 8C (CUS.IN) REXTON KMAT STERLING 20 8C (CFP) REXTON KMAT STERLING 20 8C (CFP) REXTON KMAT STERLING 20 8C (CFP) REXTON KMAT STERLING 20 8C (CFP) REXTON KMAT STERLING 30 8C (CFP) REXTON KMAT STERLING 30 8C (CFP) REXTON KMAT STERLING 30 8C (CFP) REXTON KMAT STERLING 30 8C (CFP) Connexx Connexx Connexx Connexx Rexton App Smart Connect App Smart Remote App
Model Identifier(s)
10943507 10943508 10943509 10943510 10943511 10943512 10943513 10943514 10943515 10943516 10943519 10943520 10943521 10943522 10943525 10943526 10953012 10953013 10953015 10953016 10958806 10958807 10958808 10958809 10958810 10958811 10958812 10958813 10958814 10958815 10958816 10958817 10960040 10960041 10961450 (CIC) 10961450 (IIC) 10961450 (ITC) 10961450 (ITE) 10961452 (CIC) 10961452 (IIC) 10961452 (ITC) 10961452 (ITE) 10961455 (CIC) 10961455 (IIC) 10961455 (ITC) 10961455 (ITE) 10966971 10966972 10966973 10966974 10966975 10966976 10966977 10966978 10990777 10990778 10990779 10990780 10990781 10990782 10990783 10990784 10990785 10990786 10990787 10990788 10990802 10990803 10990804 10990805 10990806 10990808 10990809 10990810 10990811 10990812 10997225(CIC) 10997225(IIC) 10997225(ITC) 10997225(ITE) 10997226(CIC) 10997226(IIC) 10997226(ITC) 10997226(ITE) 10997227(CIC) 10997227(IIC) 10997227(ITC) 10997227(ITE) 10997228 (CIC) 10997228 (IIC) 10997228 (ITC) 10997228 (ITE) Connexx V8.4.5 Connexx V8.5.15 Connexx V9.2.5 Connexx V9.3.0 Rexton App Smart Connect App Smart Remote App