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SIVANTOS VIBE HEARING AIDS (ITE, WIRELESS, DIGITAL) - HSA Registration DE0507569

Access comprehensive regulatory information for SIVANTOS VIBE 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 DE0507569 and owned by Sivantos GmbH. The device was registered on December 02, 2022.

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
DE0507569
SIVANTOS VIBE HEARING AIDS (ITE, WIRELESS, DIGITAL)
HSA Registration Number: DE0507569
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Product Description

Intended to compensate for impaired hearing that fits within the outer portion of the ear.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0507569
Registration Date
December 02, 2022
Retention Due Date
December 01, 2025
Product Owner
Short Name
Sivantos GmbH
Address
Henri- Dunant-Straฮฒe 100, 91058 Erlangen Germany, 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)
VIBE NANO 8 VIBE NANO 8 VIBE MINI 8 VIBE MINI 8 VIBE MINI 8 VIBE MINI 8 VIBE NANO 8 VIBE NANO 8 VIBE APP
Model Identifier(s)
10951922 10951923 10951924 10951925 10972036 10972037 10972038 10972039 VIBE APP