Singapore HSA registration DE0505931
Sivantos hear.com horizon Hearing Aids (ITE, Digital, Wireless)
Singapore·CLASS B·Sivantos GmbH·Registered June 25, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Ear, Nose & Throat
Registration information
- Registration Number
- DE0505931
- Registration Date
- June 25, 2021
- Change Notification Approval Date
- May 12, 2022
- Retention Due Date
- June 24, 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. ENT doctors, audiologists or acousticians.
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)
- horizon 7X CIC horizon 7X CIC horizon 5X CIC horizon 5X CIC horizon 3X CIC horizon 3X CIC horizon sDemo DX CIC horizon 7X CIC horizon 7X CIC horizon 5X CIC horizon 5X CIC horizon 3X CIC horizon 3X CIC Connexx hear.com HORIZON myREMOTE
- Model Identifier(s)
- 10981022 10981023 10981024 10981025 10981026 10981027 10981028 10981029 10981030 10981031 10981032 10981033 10981034 Connexx hear.com HORIZON myREMOTE
About this record
Access comprehensive regulatory information for Sivantos hear.com horizon Hearing Aids (ITE, Digital, Wireless) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505931 and owned by Sivantos GmbH. The device was registered on June 25, 2021.
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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