Identity
- Trade Name
- Beurer FDA UDI
- Generic Name
- Air-conduction hearing aid, wearable case FDA UDI
- Device Name
- Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compensate for impaired hearing. FDA UDI
- Model / Reference
- HA50 (Art.- No. 641.71) FDA UDI
- Description
- Wearable air-conduction hearing aid - wearable sound-amplifying device that is intended to compensate for impaired hearing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853879007027 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Air-conduction hearing aid, wearable case 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Air-conduction hearing aid, wearable case
Beurer by Beurer North America, L.p. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, wearable case.
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Beurer North America, L.p.
Sources (1)
- FDA UDI d639952f-53db-41d9-a5ef-7d16989048d8 35 fields · synced May 29, 2026