Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014844046

FEI Number

3014844046

Entity Name

XIAMEN MELOSOUND TECHNOLOGY CO.,LTD

City/State/Country

Xiamen Fujian, CN

Establishment Address

Room 117A,North Chuangye Building,Chuangye Park,Torch-Tech Zone, Xiamen Fujian 361005, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

XIAMEN MELOSOUND TECHNOLOGY CO.,LTD (Owner Number: 10058640)

Owner / Operator Contact Address

Room 117a,North Chuangye Building,, Chuangye Park,Torch-Tech Zone, Xiamen, CN-FJ 361005, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Muse 3200M, Muse 3200MB, ARIC 907, ARIC 909B, Duronix 1600 Ric, Duronix 3200 Ric, Duronix 1600 BT, Duronix 3200 BT In-The-Ear Hearing Aid, ITE, ITC-P, ITC, CIC-P, CIC, Luna RL11M, Luna 1600M, Luna 3200M, Luna 3200MB, Zeal ONE; Behind-The-Ear Hearing Aid, BTE UP, BTE SP, BTE P, ARIC P, Sonix 107, Sonix 707, Sonix 907, Sonix 909B, Muse1600M, In-The-Ear Hearing Aid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-11-22
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	2018-10-17

Official Correspondent

Kim Su

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

XIAMEN MELOSOUND 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 3014844046. Last updated year: 2026. Please use registration number 3014844046 when referencing this establishment in official correspondence.