Identity
- Trade Name
- Calibration Unit FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Model / Reference
- CAL-UNIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060396170447 FDA UDI
- FDA Product Code
- EWO FDA UDIGWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.1050 FDA UDI882.1900 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Evoked-potential audiometerOtoacoustic emission system, battery-poweredOtoacoustic emission system, line-powered
Calibration Unit by Otodynamics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Otoacoustic emission system, line-powered.
- Aria — Intelligent Hearing Systems Corp. · Class II
- Screener Cart (TUV Listed) — Intelligent Hearing Systems Corp. · Class II
- Screener Cart — Intelligent Hearing Systems Corp. · Class II
- Universal Smart Box — Intelligent Hearing Systems Corp. · Class II
- MADSEN Capella2 TE — Intelligent Hearing Systems Corp. · Class II
- Maico DE — MAICO Diagnostics GmbH · Class II
- Smart USBLite — Intelligent Hearing Systems Corp. · Class II
- Interacoustics — Interacoustics A/S · 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
- Otodynamics
Sources (1)
- FDA UDI e496203f-753e-4c69-b49a-ab39b203d021 32 fields · synced May 30, 2026