Identity
- Trade Name
- ELEHEAR Alpha Pro FDA UDI
- Generic Name
- Air-conduction hearing aid, wearable case FDA UDI
- Model / Reference
- RIC 01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 69743465514004 FDA UDI
- FDA Product Code
- QUG FDA UDI
- GMDN Term
- Air-conduction hearing aid, wearable case 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Air-conduction hearing aid, wearable case
ELEHEAR Alpha Pro by Elevoc Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, wearable case.
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class II
- Newsound — Xiamen New Sound Technology Co., Ltd. · Class I
- Newsound — Xiamen New Sound Technology Co., Ltd. · Class II
- TIANLE — Zhongshan Tianle Hearing Technology Co., Ltd. · Class I
- Aqustic — PS Hearing Products Inc · Class I
- Newsound — Xiamen New Sound Technology Co., Ltd. · 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
- Elevoc Technology Co., Ltd.
Sources (1)
- FDA UDI 4a051aa8-fa18-4b79-b3c1-13ecaf98d012 32 fields · synced May 31, 2026