Tomore Medical (Shenzhen) Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 4 products catalogued.
Tomore Medical (Shenzhen) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Hearing Aid, Air-Conduction, Prescription, Hearing Aid, Air-Conduction, Over The Counter and 2 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
4device types registered with the FDA
4products catalogued under its own name
Registration
| Registered name | Tomore Medical (Shenzhen) Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3019414808 |
| FEI number | 3019414808 |
| DUNS | 699487204 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Room 201, Building 1, Xiantaoyuan Industrial Zone, Silian Community, Henggang Street, Longgang District |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Hearing Aid(5116A(TE), 5116B(TE), 5216A(TE), 5216B(TE), 5216C(TE), 5116AE(TE), 5216AE(TE), 5118L(TE), 5118H(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(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(SyncTune, SyncTune Pro, HearDot, HearDot Pro, 5130L, 5130H, 6130, 6127, 6129, Eclarity RIC) and 2 more | 2022 | 52 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Class 2 | 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(5118DL(TE), 5118DH(TE), 5116DL(TE), 5116DH(TE), 5126H(TE), 5126L(TE), 5128H(TE), 5128L(TE), 5120L(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(5007C, 5007E, 5008C, 5008T, 5220D) and 2 more | 2022 | 29 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Hearing Aid(Eclarity LTE, Eclarity TE), Hearing Aid(IHP1216-IE, Lucid508, Lucid508-S, Lucid516 RIC, SuperMini-b, SuperMini-br, AT216, Eclarity mini), Hearing Aid(108, 1108A, 1108B, 308, 3308A, 3308B, 316, 216, 1208A, 1208B, 1216AE, 1216BE, 1118, 1120, 1122, 1124, 6116), Hearing Aid(3003, TE202, 5112, SyncTune, SyncTune Pro, HearDot), Hearing Aid(HearDot Pro, 5130L, 5130H, 6130, 6127, 6129, Eclarity RIC), Hearing Aid(1126, 1128, 6120, 6121, 6122, 6126, 6128, 5222, 5220, 5003, 5005, 5006, 5122) and 2 more | 2022 | 57 |
| Hearing Aid, Air-Conduction, Prescription | Class 1 | Hearing Aid(108(TE), 1108A(TE), 1108B(TE), 308(TE), 3308A(TE), 3308B(TE), 316(TE), 216(TE), 1208A(TE), 1208B(TE)), Hearing Aid(5120H(TE), 5116L(TE), 5116H(TE), 816TE, ADR-816TE, APT818TE, APT516TE-RIC, APT616TE-RIC, ADR-816TE), Hearing Aid(1216AE(TE), 1216BE(TE), 1118(TE), 1120(TE), 1122(TE), 1124(TE), 7116T(TE), 7116(TE), 1216TE(TE), 508OE(TE)), Hearing Aid(APT818TE, IHP1216-IE, Lucid508, Lucid508-S, Lucid516 RIC, AT216, Eclarity mini, Eclarity LTE), 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)) and 2 more | 2021 | 45 |
Own-Brand Listings
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Factory area | 3000 m² |
| Main products | RIC hearing aids, BTE hearing aids, ITE hearing aids, CIC hearing aids, Hearing aid accessories |
| Certifications | FDA, ISO 13485, 100+ patent certificates |
| Export markets | Global |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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