Audyx

Basic Information

• Brand Name: Audyx
• Primary DI: 07290017820019
• Version / Model: 2.X
• Catalog Number: N/A
• Company Name: KOALYS TECHNOLOGIES LTD
• Labeler DUNS: 600023242
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-02
• Public Version: 3
• Public Version Date: 2023-08-03
• Public Version Status: Update
• Public Device Record Key: a8c3085d-3640-454a-8834-233c7b7acfa1

Device Description

Audyx is an online audiology platform for patients care. It runs on a computing device connected to the Internet as well as to an electro-acoustic system to produce controlled signals to perform audiometric evaluation and to assist in the diagnosis of otological disorders

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37503	Tone audiometer	An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290017820019	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]