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Sign in to claim this brandTomore Healthcare (Dongguan) Co., Ltd.
US
Last updated May 23, 2026
What Tomore Healthcare (Dongguan) Co., Ltd. makes
The company manufactures air-conduction hearing aid acoustic tubes, which are used to transmit sound from hearing instruments to the ear canal. These components are designed to fit within hearing aid systems and facilitate clear auditory transmission for users with hearing loss.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with listings in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable medical device regulations for these product categories.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Tomore Healthcare (Dongguan) Co., Ltd. manufacture?
Tomore Healthcare (Dongguan) Co., Ltd. specializes in air-conduction hearing aid acoustic tubes. These devices are critical components that connect hearing instruments to the ear canal, enabling sound transmission for individuals with hearing loss. Their focus is on ensuring clear auditory pathways within hearing aid systems.
Where is Tomore Healthcare (Dongguan) Co., Ltd. based?
The company operates from the United States. While its name includes 'Dongguan,' the regulatory and operational presence is based in the US, where it aligns with applicable medical device regulations for its product categories.
Which regulatory registries list Tomore Healthcare’s devices?
Tomore Healthcare’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and traceability for air-conduction hearing aid acoustic tubes.
How are Tomore Healthcare’s devices classified under regulatory frameworks?
Tomore Healthcare’s air-conduction hearing aid acoustic tubes fall under Class I and Class II classifications. These classifications determine the regulatory oversight level based on risk: Class I devices generally pose minimal risk, while Class II devices require stricter controls due to moderate risk, such as ensuring proper performance in auditory transmission.
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
- 844874890
Catalogue (109)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tomore | CIC | FDA UDI | Class I | Active |
| Tomore | 5124 | FDA UDI | Class I | Active |
| Tomore | 5116DL | FDA UDI | Class I | Active |
| Tomore | 1122 | FDA UDI | Class II | Active |
| Tomore | 516TE | FDA UDI | Class I | Active |
| Tomore | 7116T | FDA UDI | Class I | Active |
| Tomore | SuperMini-br | FDA UDI | Class I | Active |
| Tomore | 5116DL | FDA UDI | Class II | Active |
| Tomore | 5120H | FDA UDI | Class I | Active |
| Tomore | 5118L | FDA UDI | Class II | Active |
| Tomore | One-FIT-ALL-In-THE-E AR Hearing Aids(Faceplate Kits Included) | FDA UDI | Class II | Active |
| Tomore | IHP1216-IE | FDA UDI | Class I | Active |
| Tomore | Necklace Hearing Aid | FDA UDI | Class I | Active |
| Tomore | 816TE | FDA UDI | Class II | Active |
| Tomore | 5216B | FDA UDI | Class II | Active |
| Tomore | 5120 | FDA UDI | Class I | Active |
| Tomore | 5118DH | FDA UDI | Class II | Active |
| Tomore | APT818TE | FDA UDI | Class II | Active |
| Tomore | 1208B | FDA UDI | Class I | Active |
| Tomore | 1118 | FDA UDI | Class I | Active |
| Tomore | APT516TE-RIC | FDA UDI | Class II | Active |
| Tomore | 308 | FDA UDI | Class I | Active |
| Tomore | Analog Hearing Aids | FDA UDI | Class II | Active |
| Tomore | One-FIT-ALL-In-THE-E AR Hearing Aid(Faceplate Kits Included) | FDA UDI | Class I | Active |
| Tomore | 5216AE | FDA UDI | Class II | Active |
| Tomore | 5126 | FDA UDI | Class I | Active |
| Tomore | Eclarity LTE | FDA UDI | Class I | Active |
| Tomore | BTE | FDA UDI | Class I | Active |
| Tomore | 5122 | FDA UDI | Class I | Active |
| Tomore | 5216AE | FDA UDI | Class I | Active |
| Tomore | In-THE-EAR-Hearing Aid(Faceplate Kits Included) | FDA UDI | Class I | Active |
| Tomore | 5116B | FDA UDI | Class II | Active |
| Tomore | Open Fit | FDA UDI | Class I | Active |
| Tomore | 1120 | FDA UDI | Class I | Active |
| Tomore | 108 | FDA UDI | Class I | Active |
| Tomore | RIC | FDA UDI | Class II | Active |
| Tomore | Lucid516 RIC | FDA UDI | Class I | Active |
| Tomore | 6116 | FDA UDI | Class I | Active |
| Tomore | 5118L | FDA UDI | Class II | Active |
| Tomore | 5120H | FDA UDI | Class II | Active |
| Tomore | 1108B | FDA UDI | Class I | Active |
| Tomore | 5120L | FDA UDI | Class I | Active |
| Tomore | 7116T | FDA UDI | Class II | Active |
| Tomore | 7116 | FDA UDI | Class I | Active |
| Tomore | 1108A | FDA UDI | Class I | Active |
| Tomore | 516TE | FDA UDI | Class II | Active |
| Tomore | 1124 | FDA UDI | Class I | Active |
| Tomore | 5116AE | FDA UDI | Class I | Active |
| Tomore | APT616TE-RIC | FDA UDI | Class II | Active |
| Tomore | Eclarity LTE | FDA UDI | Class II | Active |
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