gudid
Primary ID: ACA
HearLab (UDI ACA)
Manufactured by FRYE ELECTRONICS, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HearLab - Primary ID ACA
Device Regulatory Overview
The HearLab (Model/Catalog Number: ACA) is a medical device manufactured by FRYE ELECTRONICS, INC.. This product is indexed under FDA Product Code / Category Classification GWJ within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ACA
- Product Code / EMDN
- GWJ
- Device Name
- Database Sync Date
- 2026-08-09 09:43:50
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 HearLab?
The registered manufacturer of record for HearLab is FRYE ELECTRONICS, INC..
What is the Primary UDI-DI identifier for HearLab?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ACA.
What classification code is assigned to this device?
This device is registered under product classification code GWJ.
Similar Classification Devices (GWJ)
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