FDA Registration
Active
🇨🇳 China
Tomore Medical (Shenzhen) Co., Ltd
Reg #: 3019414808
·
FEI: 3019414808
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Tomore Medical (Shenzhen) Co., Ltd
- Registration Number
- 3019414808
- FEI Number
- 3019414808
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 201, Building 1, Xiantaoyuan Industrial Zone, Silian Community, Henggang Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- Tomore Medical (Shenzhen) Co., Ltd
- Operator Number
- 10081686
- Address
- Room 201, Building 1, Xiantaoyuan Industrial Zone, Silian Community, Henggang Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518000
- Country
- CN
- Correspondent
- Xue Li
US Agent
- Business Name
- SPICA MEDTECH CORP
- Contact Name
- Creekon Yang
- Address
- 1020 LINCOLN ST
- City
- Denver
- State
- CO
- ZIP
- 80203
- Country
- US
- [email protected]
- Phone
- 720 6176666
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | Class 2 | Ear, Nose, Throat | No | 2022-12-15 |
| Hearing Aid, Air-Conduction, Prescription | ESD | Class 1 | Ear, Nose, Throat | No | 2021-05-06 |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | Class 2 | Ear, Nose, Throat | No | 2022-05-17 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2022-12-15 |
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(5007C, 5007E, 5008C, 5008T, 5220D, 6001, 6002, 6003, 6005, 6006)
Hearing Aid(5007C, 5007E, 5008C, 5008T, 5220D)
Hearing Aid(3003, TE202, 5112, SyncTune, SyncTune Pro, HearDot)
Hearing Aid(IHP1216-IE, Lucid508, Lucid508-S, Lucid516 RIC, SuperMini-b, SuperMini-br, AT216, Eclarity mini)
Hearing Aid(Eclarity LTE, Eclarity TE)
Hearing Aid(1126, 1128, 6120, 6121, 6122, 6126, 6128, 5222, 5220, 5003, 5005, 5006, 5122)
Hearing Aid(HearDot Pro, 5130L, 5130H, 6130, 6127, 6129, Eclarity RIC)
Hearing Aid(108, 1108A, 1108B, 308, 3308A, 3308B, 316, 216, 1208A, 1208B, 1216AE, 1216BE, 1118, 1120, 1122, 1124, 6116)
Hearing Aid(6116A, 6118, 7116T, 7116, 1216TE, 5001H, 5001L, 508OE, 5116A, 5116B, 5216A, 5216B, 5216C, 5116AE, 5216AE)
Hearing Aid(5118L, 5118H, 5118DL, 5118DH, 5116DL, 5116DH, 5126H, 5126L, 5128H, 5128L, 5120L, 5120H, 5116L, 5116H, 816TE)
Establishment Types
Manufacture Medical Device