FDA Registration Active 🇨🇳 China

Vista T

Reg #: 3004929038 · FEI: 3004929038 · Expires 2025
Products
1
Proprietary Names
73
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Sonova Hearing (Suzhou) Co., Ltd.
Registration Number
3004929038
FEI Number
3004929038
Status
Active
Expiry Year
2025
Initial Importer
No
Address
NO.78, QI MING ROAD, Comprehensive Bonded Zone, Suzhou Industrial Park,
City
Suzhou Jiangsu
Country
CN

Regulatory Submissions

510(k) Number
K123450

Owner / Operator

Firm Name
Sonova AG
Operator Number
9028479
Address
Laubisruetistrasse 28
City
Staefa
State
Zurich
Postal Code
8712
Country
CH

US Agent

Business Name
Sonova USA Inc.
Contact Name
Jennifer Penn
Address
444 Commerce Street
City
Aurora
State
IL
ZIP
60504
Country
US
Phone
331 2194696

Products

Device Name Product Code
Masker, Tinnitus KLW

Proprietary Names

Vista T ampli-mini I 5P CIC-10 NWL PH Aura:fit Relate Au B Unitron TrueFit Au 3 Vista S Sennheiser Sonite R RELATE 2 Phonak Naida P Phonak Bolero M ampli-energy B Trial L Stride V Relate3.1 Phonak Naida L Star Evolution Au Basic+ AudioNova S Phonak Audeo L-R Fit DX Insera Moxi B Relate4 Relate 5 Moxi S Phonak Virto M Easy Line Remote Phonak Audeo I-Sphere AudioNova DX ampli-connect R L PH Unitron Remote Plus Phonak Virto I Vista B AudioNova B Phonak Brio 5 Move DX Stride P R MEMINI I 5P CIC-10 NWL PH AudioNova T ampli-connect R Trial L Hearing Remote Phonak Audeo L Phonak Naida M ampli-mini R L PH HANSATON stream remote Relate3 HelloGO Phonak Target Au V T Moxi Insera B T Insera AudioNova V Aura:fit AudioNova Phonak Virto P Phonak Audeo I Vista DX Phonak Brio 5 I DX Stride M ampli-energy R 5P R PH Phonak Audeo P-R Fit Phonak Audeo P-RL ampli-energy B L RP PH Phonak Audeo P Stride B MEMINI E P R-R PH ampli-energy R Trial 5P myPhonak T Max Vista V Aura:fit T Stride Moxi V Phonak Audeo M Sonite R Kit

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)