Earscan 3 ES3M
Earscan 3 ES3M (06.001) is a Class II device made by Micro Audiometrics Corp., listed in FDA GUDID since 7 Sep 2016 (UDI-DI 00862185000301), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00862185000301 | Date7 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00862185000301
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Earscan 3
- Generic name
- Tone audiometer
- Model / Ref / Catalog
- ES3M, 06.001
- Primary DI / UDI-DI
- 00862185000301
- FDA product code
- EWO
- GMDN term
- Tone audiometer
- Device class
- Class II
- Regulation number
- 874.1050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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