GUDIDData
eudamed_udi Primary ID: 00840388211311

Audibel Aris AI 20 ITE R (UDI 00840388211311)

Manufactured by Starkey Laboratories Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Audibel Aris AI 20 ITE R - Primary ID 00840388211311

Device Regulatory Overview

The Audibel Aris AI 20 ITE R (Model/Catalog Number: 72145-ABL) is a medical device manufactured by Starkey Laboratories Inc.. This product is indexed under FDA Product Code / Category Classification Y2145060201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
72145-ABL
Product Code / EMDN
Y2145060201
Device Name
Omega AI Custom
Database Sync Date
2026-08-09 16:48:33

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Audibel Aris AI 20 ITE R?

The registered manufacturer of record for Audibel Aris AI 20 ITE R is Starkey Laboratories Inc..

What is the Primary UDI-DI identifier for Audibel Aris AI 20 ITE R?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00840388211311.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060201.

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