gudid
Primary ID: FP35
Fonix (UDI FP35)
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 FP35
Device Regulatory Overview
The Fonix (Model/Catalog Number: FP35) is a medical device manufactured by FRYE ELECTRONICS, INC.. This product is indexed under FDA Product Code / Category Classification EWO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- FP35
- Product Code / EMDN
- EWO
- Device Name
- The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It uses a graphical display or numerical table to show how much amplification the aid provides, which frequencies it amplifies, and how much distortion is creates. The FP35 analyzer is meant to be used primarily by hearing health professionals who fit hearing aids on hearing-impaired adults and children throughout the world.
- Database Sync Date
- 2026-08-09 09:51:18
Full Regulatory Attributes
🔒 Token Gated
{
"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 FP35.
What classification code is assigned to this device?
This device is registered under product classification code EWO.
Similar Classification Devices (EWO)
Other Devices by FRYE ELECTRONICS, INC.
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