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Sivantos hear.com horizon Hearing Aids (ITE, Digital, Wireless) - HSA Registration DE0505931

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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CLASS B
DE0505931
Sivantos hear.com horizon Hearing Aids (ITE, Digital, Wireless)
HSA Registration Number: DE0505931
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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. ENT doctors, audiologists or acousticians.

Device 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 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)
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