Identity
- Trade Name
- Bernafon FDA UDI
- Generic Name
- Hearing aid neck induction loop, wireless input FDA UDI
- Device Name
- SOUNDGATE 2.0, NO LOGO FDA UDI
- Model / Reference
- 131233 FDA UDI
- Description
- SOUNDGATE 2.0, NO LOGO FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05711584050361 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Hearing aid neck induction loop, wireless input 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Hearing aid neck induction loop, wireless input
Bernafon by Oticon A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hearing aid neck induction loop, wireless input.
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class I
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class II
- Bernafon — Bernafon, Inc. · Class II
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class II
- YI ANG — Jiangxi Yi Ang Medical Technology Co., Ltd · Class II
- Phonak — Phonak, Inc. · Class I
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class I
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Oticon A/S
Sources (1)
- FDA UDI f38b0705-9369-473d-b501-d6119880e334 35 fields · synced Jun 8, 2026