Identity
- Trade Name
- Etymotic Research, Inc. FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- Changing tool with filters(orange) HHT FDA UDI
- Model / Reference
- ER38-46HHT FDA UDI
- Description
- Changing tool with filters(orange) HHT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00846430004009 FDA UDI
- FDA Product Code
- EWO FDA UDI
- GMDN Term
- Tone audiometer 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
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: Tone audiometer
Etymotic Research, Inc. by Etymotic Research, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tone audiometer.
- TREMETRICS — MAICO Diagnostics GmbH · Class II
- SHOEBOX AUDIOMETRY — SHOEBOX Ltd · Class II
- nanoAudio DD45 Set with Patient Response Button and Hughson-Westlake — PATH medical GmbH · Class II
- Otometrics — Natus Medical Denmark ApS · Class II
- TRIANGLE — INVENTIS SRL · Class II
- Benson — MAICO Diagnostics GmbH · Class II
- Maico — MAICO Diagnostics GmbH · Class II
- VIOLA — INVENTIS SRL · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Etymotic Research, Inc.
Sources (1)
- FDA UDI 09e9fe9a-2bed-4dab-a2ff-5d0eb07d11ad 33 fields · synced May 30, 2026