GUDIDData
eudamed_udi Primary ID: 00840388204696

Afflelou Incognito Edge AI 16 CIC (UDI 00840388204696)

Manufactured by Starkey Laboratories Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Afflelou Incognito Edge AI 16 CIC - Primary ID 00840388204696

Device Regulatory Overview

The Afflelou Incognito Edge AI 16 CIC (Model/Catalog Number: 72098-FLE) is a medical device manufactured by Starkey Laboratories Inc.. This product is indexed under FDA Product Code / Category Classification Y2145060203 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
72098-FLE
Product Code / EMDN
Y2145060203
Device Name
Edge AI Custom
Database Sync Date
2026-08-09 16:29:34

Full Regulatory Attributes

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Afflelou Incognito Edge AI 16 CIC?

The registered manufacturer of record for Afflelou Incognito Edge AI 16 CIC is Starkey Laboratories Inc..

What is the Primary UDI-DI identifier for Afflelou Incognito Edge AI 16 CIC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00840388204696.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060203.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint