gudid
Primary ID: 8000
Fonix (UDI 8000)
Manufactured by FRYE ELECTRONICS, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Fonix - Primary ID 8000
Device Regulatory Overview
The Fonix (Model/Catalog Number: 8000) is a medical device manufactured by FRYE ELECTRONICS, INC.. This product is indexed under FDA Product Code / Category Classification ETW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 8000
- Product Code / EMDN
- ETW
- Device Name
- The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, battery current drain, and frequency response to advanced tests of digital processing delay and phase. The FONIX 8000 is composed of a main electronics module with a front panelfor controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results.
- Database Sync Date
- 2026-08-09 09:51:18
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Fonix?
The registered manufacturer of record for Fonix is FRYE ELECTRONICS, INC..
What is the Primary UDI-DI identifier for Fonix?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8000.
What classification code is assigned to this device?
This device is registered under product classification code ETW.
Similar Classification Devices (ETW)
Other Devices by FRYE ELECTRONICS, INC.
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