Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030396448

FEI Number

3030396448

Entity Name

XIAMEN VIENATONE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

8th Floor, Block A, Jianye Building, No. 96 Xiangxing Road, Xiamen Torch High-Tech Zone (Xiang an) Industrial Zone, Xiamen Fujian 361101, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Xiamen Vienatone Medical Technology Co., Ltd. (Owner Number: 10089482)

Owner / Operator Contact Address

8th Floor, Block A, Jianye Building, No. 96 Xiangxing Road, Xiamen Torch High-Tech Zone (Xiang'an)Industrial Zone, Xiamen, CN-FJ 361101, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FACE PLATE HEARING AID LY CR230 TY CN430S CN223 CN130S Behind-The-Ear Hearing Aid Samba R11 jiaquanCN430S Mini series In-The-Ear Hearing Aid PISnet HearClean Hearing Aid, Air-Conduction, Over The Counter Falcon CF430S E-08 Ballet series In-The-Ear Hearing Aid Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter Behind-The-Ear Hearing Aid ion Pro Navo series iBstone Edge series ion Pro 2 Discovery series Explore Li+ RC07-02 RC07-01

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	2023-12-11
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2023-12-11
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Xiamen Vienatone Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030396448. Last updated year: 2026. Please use registration number 3030396448 when referencing this establishment in official correspondence.