Hearing Test Feature V1.0
by Samsung Electronics Co., Ltd.
Hearing Test Feature V1.0 is a Class II device made by Samsung Electronics Co., Ltd., listed in FDA GUDID since 19 Oct 2026 (UDI-DI 08806099222635), registry data as of 2 Nov 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08806099222635 | Date19 Oct 2026 | StatusListed |
Official records
- AccessGUDID record 08806099222635
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Hearing Test Feature
- Generic name
- Self-testing tone audiometer
- Model / reference
- V1.0
- Primary DI / UDI-DI
- 08806099222635
- FDA product code
- EWO
- GMDN term
- Self-testing tone audiometer
- Device class
- Class II
- Regulation number
- 874.1050
- GUDID distribution status
- In Commercial Distribution
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