Identity
- Trade Name
- KUDUwave FDA UDI
- Generic Name
- Tone audiometer FDA UDI
- Device Name
- An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. FDA UDI
- Model / Reference
- KUDUwave Prime FDA UDI
- Description
- An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06009900487816 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tone audiometer
KUDUwave by Emoyodotnetza (pty) Ltd — 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 |
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Manufacturer
- Manufacturer
- Emoyodotnetza (pty) Ltd
Sources (1)
- FDA UDI 6110d362-0958-4696-b999-177c47ea8f42 33 fields · synced May 30, 2026