Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019414808

FEI Number

3019414808

Entity Name

Tomore Medical (Shenzhen) Co., Ltd

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 201, Building 1, Xiantaoyuan Industrial Zone, Silian Community, Henggang Street, Longgang District, Shenzhen Guangdong 518000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tomore Medical (Shenzhen) Co., Ltd (Owner Number: 10081686)

Owner / Operator Contact Address

Room 201, Building 1, Xiantaoyuan Industrial Zone, Silian Community, Henggang Street, Longgang District, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hearing Aid(SyncTune, SyncTune Pro, HearDot, HearDot Pro, 5130L, 5130H, 6130, 6127, 6129, Eclarity RIC) Hearing Aid(1216AE(TE), 1216BE(TE), 1118(TE), 1120(TE), 1122(TE), 1124(TE), 7116T(TE), 7116(TE), 1216TE(TE), 508OE(TE)) Hearing Aid(Eclarity TE, 5222(TE), 5220(TE), 5003(TE), 5005(TE), 5006(TE), 5122(TE)) Hearing Aid(5116A(TE), 5116B(TE), 5216A(TE), 5216B(TE), 5216C(TE), 5116AE(TE), 5216AE(TE), 5118L(TE), 5118H(TE)) Hearing Aid(5118DL(TE), 5118DH(TE), 5116DL(TE), 5116DH(TE), 5126H(TE), 5126L(TE), 5128H(TE), 5128L(TE), 5120L(TE)) Hearing Aid(APT818TE, IHP1216-IE, Lucid508, Lucid508-S, Lucid516 RIC, AT216, Eclarity mini, Eclarity LTE) Hearing Aid(5120H(TE), 5116L(TE), 5116H(TE), 816TE, ADR-816TE, APT818TE, APT516TE-RIC, APT616TE-RIC, ADR-816TE) Hearing Aid(108(TE), 1108A(TE), 1108B(TE), 308(TE), 3308A(TE), 3308B(TE), 316(TE), 216(TE), 1208A(TE), 1208B(TE)) Hearing Aid(Eclarity TE, 5222(TE), 5220(TE), 5003(TE), 5005(TE), 5006(TE), 5122(TE)) Hearing Aid(APT818TE, IHP1216-IE, Lucid508, Lucid508-S, Lucid516 RIC, AT216, Eclarity mini, Eclarity LTE) Hearing Aid(5116A(TE), 5116B(TE), 5216A(TE), 5216B(TE), 5216C(TE), 5116AE(TE), 5216AE(TE), 5118L(TE), 5118H(TE)) Hearing Aid(108(TE), 1108A(TE), 1108B(TE), 308(TE), 3308A(TE), 3308B(TE), 316(TE), 216(TE), 1208A(TE), 1208B(TE)) Hearing Aid(1216AE(TE), 1216BE(TE), 1118(TE), 1120(TE), 1122(TE), 1124(TE), 7116T(TE), 7116(TE), 1216TE(TE), 508OE(TE)) Hearing Aid(5120H(TE), 5116L(TE), 5116H(TE), 816TE, ADR-816TE, APT818TE, APT516TE-RIC, APT616TE-RIC, ADR-816TE) Hearing Aid(5007C, 5007E, 5008C, 5008T, 5220D, 6001, 6002, 6003, 6005, 6006) Hearing Aid(5118DL(TE), 5118DH(TE), 5116DL(TE), 5116DH(TE), 5126H(TE), 5126L(TE), 5128H(TE), 5128L(TE), 5120L(TE)) Hearing Aid(1216AE(TE), 1216BE(TE), 1118(TE), 1120(TE), 1122(TE), 1124(TE), 7116T(TE), 7116(TE), 1216TE(TE), 508OE(TE)) Hearing Aid(5116A(TE), 5116B(TE), 5216A(TE), 5216B(TE), 5216C(TE), 5116AE(TE), 5216AE(TE), 5118L(TE), 5118H(TE)) Hearing Aid(108(TE), 1108A(TE), 1108B(TE), 308(TE), 3308A(TE), 3308B(TE), 316(TE), 216(TE), 1208A(TE), 1208B(TE)) Hearing Aid(Eclarity TE, 5222(TE), 5220(TE), 5003(TE), 5005(TE), 5006(TE), 5122(TE)) Hearing Aid(5118DL(TE), 5118DH(TE), 5116DL(TE), 5116DH(TE), 5126H(TE), 5126L(TE), 5128H(TE), 5128L(TE), 5120L(TE)) Hearing Aid(5120H(TE), 5116L(TE), 5116H(TE), 816TE, ADR-816TE, APT818TE, APT516TE-RIC, APT616TE-RIC, ADR-816TE) Hearing Aid(APT818TE, IHP1216-IE, Lucid508, Lucid508-S, Lucid516 RIC, AT216, Eclarity mini, Eclarity LTE) Hearing Aid(5007C, 5007E, 5008C, 5008T, 5220D)

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	2022-12-15
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2021-05-06
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2022-05-17

Official Correspondent

Xue Li

US Agent Details

Creekon Yang Business: SPICA MEDTECH CORP Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Tomore Medical (Shenzhen) Co., Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019414808. Last updated year: 2026. Please use registration number 3019414808 when referencing this establishment in official correspondence.