Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034733579

FEI Number

3034733579

Entity Name

SHENZHEN FLYSOUNDS MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 1816 Floor, Building A, Jindingshengkechuang Park, No. 356, Dahe Road Qinghu Community, Longhua Street, Longhua District,, Shenzhen Guangdong 518109, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Shenzhen Flysounds Medical Technology Co., Ltd. (Owner Number: 10092282)

Owner / Operator Contact Address

Room 1816, Building A, Jindingshengkechuang Park, No. 356, Dahe Road, Qinghu Community, Longhua Street, Longhua District, Shenzhen, CN-GD 518109, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FS-R37,FS-R38,FS-R39,FS-R40FS-B1,FS-B2FS-B3,FS-B4,FS-B5,FS-B6,FS-B7,FS-B8,FS-B9,FS-B10,FS-B11,FS-B12,FS-B13,FS-B14 FS-B4,FS-B5,FS-B6,FS-B7,FS-B8,FS-B9,FS-B10,FS-B11,FS-B12,FS-B13,FS-B14,FS-B15,FS-B16,FS-B17,FS-B18,FS-B19 FS-R26,FS-R27,FS-R28,FS-R29FS-R30,FS-R31,FS-R32,FS-R33,FS-R34,FS-R35,FS-R36 FS-B31,FS-B32,FS-B33,FS-B34,FS-B35,FS-B36,FS-B37,FS-B38,FS-B39,FS-B40FS-B1,FS-B2,FS-B3 FS-B20,FS-B21,FS-B22,FS-B23,FS-B24,FS-B25,FS-B26,FS-B27,FS-B28,FS-B29,FS-B30 B15,B16,B17,B18,B19,B20,B21,B22,B23,B24,B25,B26,B27,B28,B29,B30,B31,B32,B33,B34,B35,B36,B37,B38,B39,B40 FS-B15,FS-B16FS-B17,FS-B18,FS-B19,FS-B20,FS-B21,FS-B22,FS-B23,FS-B24,FS-B25,FS-B26,FS-B27,FS-B28,FS-B29,FS-B30 FSH8-50,FSH8-50P,FSH8-24,FSH8-24P,FSH8-16,FSH8-16P,FSH9-50,FSH9-24,FSH9-16 H27,H28,H29,H30,H31,H32,H33,H34,H35,H36,H37,H38,H39,H40,FS-R1,FS-R2,FS-R3,FS-R4,FS-R5,FS-R6,FS-R7,FS-R8,FS-R9,FS-R10 FS-B31,FS-B32,FS-B33,FS-B34,FS-B35,FS-B36,FS-B37,FS-B38,FS-B39,FS-B40R01,R02,R03R04 R31,R32,R33,R34,R35,R36,R37,R38,R39,R40B01,B02,B03,B04,B05,B06,B07,B08,B09,B10,B11,B12,B13,B14 FS-R11,FS-R12,FS-R13,FS-R14,FS-R15,FS-R16,FS-R17,FS-R18,FS-R19,FS-R20,FS-R21,FS-R22,FS-R23,FS-R24,FS-R25 R05,R06,R07,R08,R09,R10,R11,R12,R13,R14,R15,R16,R17,R18,R19,R20,R21,R22,R23,R24,R25R26,R27,R28,R29,R30 Flysound Hearing Aid,H1,H2,H3,H4,H5,H6,H7,H8,H9,H10,H11,H12,H13,H14,H15,H16,H17,H18,H19,H20,H21,H22,H23,H24,,H25,H26 ClearDry AeroVapor VaultX NanoDry X SonicDry Superdry ultra Aegis Dry DryPro T55 SilentDry Pro AeroDry

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2024-12-19
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen Flysounds 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 3034733579. Last updated year: 2026. Please use registration number 3034733579 when referencing this establishment in official correspondence.