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SIVANTOS VIBE HEARING AIDS (BTE, WIRELESS, DIGITAL) - HSA Registration DE0507568

Access comprehensive regulatory information for SIVANTOS VIBE HEARING AIDS (BTE, 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 DE0507568 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
DE0507568
SIVANTOS VIBE HEARING AIDS (BTE, WIRELESS, DIGITAL)
HSA Registration Number: DE0507568
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Product Description

Intended to help provide hearing sensation to a hearing impaired person by transmitting amplified sounds to the eardrum.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0507568
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 P8 VIBE P8 VIBE S8 VIBE S8 VIBE SP6 VIBE P6 VIBE P4 VIBE P8 VIBE S8 VIBE P 6 VIBE P 4 VIBE APP
Model Identifier(s)
10952964 10953107 10953307 10953331 10964969 10964973 10964975 10972030 10972033 10972047 10972048 VIBE APP