Identity
- Trade Name
- TOMORE FDA UDI
- Generic Name
- Air-conduction hearing aid acoustic tube FDA UDI
- Device Name
- Hearing Aid FDA UDI
- Model / Reference
- APT516TE-RIC FDA UDI
- Description
- Hearing Aid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06977275990777 FDA UDI
- FDA Product Code
- QUG FDA UDI
- GMDN Term
- Air-conduction hearing aid acoustic tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid acoustic tube
Tomore by Tomore Healthcare (Dongguan) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid acoustic tube.
- GN Hearing — Gn Hearing A/S · Class II
- TOMORE — Tomore Medical (Shenzhen) Co., Ltd · Class II
- TOMORE — Tomore Medical (Shenzhen) Co., Ltd · Class I
- GN Hearing — Gn Hearing A/S · Class II
- TOMORE — Tomore Medical (Shenzhen) Co., Ltd · Class I
- TOMORE — Tomore Medical (Shenzhen) Co., Ltd · Class II
- TOMORE — Tomore Medical (Shenzhen) Co., Ltd · Class I
- Silicone Tubing — Dreve Otoplastik GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tomore Healthcare (Dongguan) Co., Ltd.
Sources (1)
- FDA UDI 1152268c-a4fe-49a7-a8bd-d00fc9b7ccd1 33 fields · synced May 30, 2026