Identity
- Trade Name
- Earscan 3 FDA UDI
- Generic Name
- Tone audiometer, automated FDA UDI
- Device Name
- Earscan 3 Automatic Threshold Audiometer. FDA UDI
- Model / Reference
- ES3 FDA UDI
- Description
- Earscan 3 Automatic Threshold Audiometer. FDA UDI
Identifiers
- Catalog Number
- 05.001 FDA UDI
- Primary DI / UDI-DI
- 00862185000325 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Tone audiometer, automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 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
No
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 Safe FDA UDI
Category: Tone audiometer, automated
Earscan 3 by Micro Audiometrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer, automated.
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- Otogram — Ototronix, LLC · Class II
- AMBCO — AMBCO ELECTRONICS · Class II
- AMBCO — AMBCO ELECTRONICS · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Otogram — Ototronix, LLC · 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
- Micro Audiometrics Corp.
Sources (1)
- FDA UDI f1c25859-8247-476b-a23b-bce89900d889 35 fields · synced May 31, 2026