Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014990990

FEI Number

3014990990

Entity Name

SONITUS MEDICAL (SHANGHAI) CO., LTD.

City/State/Country

shanghai, CN

Establishment Address

Floor 5, Bldg. 11 & Floor 4-5, Bldg. 7, 500 Furonghua Rd, Pudong, Shanghai, shanghai 201318, CN

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sonitus Medical (Shanghai) Co., Ltd. (Owner Number: 10060074)

Owner / Operator Contact Address

Bldg.11-F5/7-F4&5, 500 Furonghua Rd., Pudong District, shanghai, CN-SH 201318, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100649

PMA Number

N/A

All Registered Proprietary Names

SoundBite SoundBite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2019-04-27
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	Class 2	874.3302	2019-04-27

Official Correspondent

yang ji

US Agent Details

AARON BEREZ Business: Alembic, LLC Email: aberez@alembicllc.com Phone: (650) 3885088

Related Public Records

Same Entity

Sonitus Medical (Shanghai) 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 3014990990. Last updated year: 2026. Please use registration number 3014990990 when referencing this establishment in official correspondence.