Identity
- Trade Name
- TOMORE FDA UDI
- Generic Name
- Air-conduction hearing aid acoustic tube FDA UDI
- Device Name
- Hearing Aid FDA UDI
- Model / Reference
- 1126 FDA UDI
- Description
- Hearing Aid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976110831978 FDA UDI
- FDA Product Code
- QUF FDA UDI
- GMDN Term
- Air-conduction hearing aid acoustic tube FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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 Medical (Shenzhen) Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid acoustic tube.
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- Tubing — Dreve Otoplastik GmbH · Class I
- TOMORE — Tomore Healthcare (Dongguan) Co., Ltd. · Class II
- TOMORE — Tomore Healthcare (Dongguan) Co., Ltd. · Class II
- GN Hearing — Gn Hearing A/S · Class II
- GN Hearing — Gn Hearing A/S · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- Tomore Medical (Shenzhen) Co., Ltd
Sources (1)
- FDA UDI 46b74c91-f28e-419c-a948-68313aea13c6 33 fields · synced May 31, 2026