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Sign in to claim this brandTomore Medical (Shenzhen) Co., Ltd
US
Last updated May 23, 2026
What Tomore Medical (Shenzhen) Co., Ltd makes
Tomore Medical (Shenzhen) Co., Ltd makes air-conduction hearing aid acoustic tubes, which are a type of medical device used in hearing aids. Their products, such as those in the TOMORE line, are designed for use in hearing aids. These devices are specific types of tubes used in hearing aids.
The company's portfolio is regulated and listed in the fda_udi registry, with devices classified as either Class I or Class II. The company is based in the US and its devices are subject to regulatory oversight.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Tomore Medical (Shenzhen) Co., Ltd make?
Tomore Medical (Shenzhen) Co., Ltd makes air-conduction hearing aid acoustic tubes, which are components used in hearing aids to transmit sound. These devices are specifically designed for use in hearing aid systems and are part of the TOMORE product line. The company’s portfolio consists of these types of tubes, which are regulated as medical devices.
Where is Tomore Medical (Shenzhen) Co., Ltd based?
Tomore Medical (Shenzhen) Co., Ltd is based in the United States, as indicated in the provided data. This location is relevant for understanding the regulatory jurisdiction under which the company operates and lists its devices.
Which regulatory registries list Tomore Medical (Shenzhen) Co., Ltd's devices?
The devices made by Tomore Medical (Shenzhen) Co., Ltd are listed in the FDA UDI (Unique Device Identification) registry. This registry is used to track and identify medical devices in the U.S. market, and the company’s products are included there as part of regulatory compliance.
How are Tomore Medical (Shenzhen) Co., Ltd's devices classified?
The devices produced by Tomore Medical (Shenzhen) Co., Ltd are classified as either Class I or Class II medical devices. This classification reflects the level of regulatory control required, with Class I being low risk and Class II requiring additional controls such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 699487204
Catalogue (256)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tomore | 5006(TE) | FDA UDI | Class I | Active |
| Tomore | 5116DH(TE) | FDA UDI | Class II | Active |
| Tomore | 5120H(TE) | FDA UDI | Class II | Active |
| Tomore | 5216AE(TE) | FDA UDI | Class II | Active |
| Tomore | 5216A(TE) | FDA UDI | Class II | Active |
| Tomore | 1216BE(TE) | FDA UDI | Class II | Active |
| Tomore | 5116B(TE) | FDA UDI | Class II | Active |
| Tomore | 1208B(TE) | FDA UDI | Class II | Active |
| Tomore | Eclarity mini | FDA UDI | Class II | Active |
| Tomore | 5116A(TE) | FDA UDI | Class II | Active |
| Tomore | 1108B(TE) | FDA UDI | Class I | Active |
| Tomore | 5118DH(TE) | FDA UDI | Class I | Active |
| Tomore | 6118 | FDA UDI | Class I | Active |
| Tomore | 5118H(TE) | FDA UDI | Class II | Active |
| Tomore | 5001L | FDA UDI | Class I | Active |
| Tomore | 5116L(TE) | FDA UDI | Class II | Active |
| Tomore | APT616TE-RIC | FDA UDI | Class I | Active |
| Tomore | 5126L(TE) | FDA UDI | Class II | Active |
| Tomore | ADR-816TE | FDA UDI | Class II | Active |
| Tomore | 5116DL | FDA UDI | Class I | Active |
| Tomore | 5122(TE) | FDA UDI | Class I | Active |
| Tomore | Lucid508-S | FDA UDI | Class I | Active |
| Tomore | 5116A(TE) | FDA UDI | Class II | Active |
| Tomore | 7116T(TE) | FDA UDI | Class I | Active |
| Tomore | APT616TE-RIC | FDA UDI | Class II | Active |
| Tomore | 5120H | FDA UDI | Class I | Active |
| Tomore | APT818TE | FDA UDI | Class II | Active |
| Tomore | 7116 | FDA UDI | Class I | Active |
| Tomore | 5216C | FDA UDI | Class I | Active |
| Tomore | Eclarity mini | FDA UDI | Class I | Active |
| Tomore | 5220(TE) | FDA UDI | Class II | Active |
| Tomore | 5116L(TE) | FDA UDI | Class I | Active |
| Tomore | Eclarity LTE | FDA UDI | Class II | Active |
| Tomore | 5120H(TE) | FDA UDI | Class I | Active |
| Tomore | 5116DH | FDA UDI | Class I | Active |
| Tomore | 5126L | FDA UDI | Class I | Active |
| Tomore | 5222 | FDA UDI | Class I | Active |
| Tomore | 108(TE) | FDA UDI | Class II | Active |
| Tomore | 1108A | FDA UDI | Class I | Active |
| Tomore | 5128L(TE) | FDA UDI | Class II | Active |
| Tomore | 1108B(TE) | FDA UDI | Class II | Active |
| Tomore | APT818TE | FDA UDI | Class II | Active |
| Tomore | 5216AE(TE) | FDA UDI | Class I | Active |
| Tomore | 5116B(TE) | FDA UDI | Class I | Active |
| Tomore | 1120(TE) | FDA UDI | Class II | Active |
| Tomore | 5120L(TE) | FDA UDI | Class I | Active |
| Tomore | 3308B(TE) | FDA UDI | Class II | Active |
| Tomore | 5003(TE) | FDA UDI | Class II | Active |
| Tomore | 5216B(TE) | FDA UDI | Class II | Active |
| Tomore | 5118L(TE) | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Tomore Medical (Shenzhen) Co., Ltd Shenzhen Guangdong · CN FEI 3019414808