gudid Primary ID: Incognito OM AI CROS RIC RT

AFFLELOU (UDI Incognito OM AI CROS RIC RT)

Manufactured by Starkey Laboratories, Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The AFFLELOU (Model/Catalog Number: Incognito OM AI CROS RIC RT) is a medical device manufactured by Starkey Laboratories, Inc.. This product is indexed under FDA Product Code / Category Classification KLW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Incognito OM AI CROS RIC RT
Product Code / EMDN: KLW
Device Name
Database Sync Date: 2026-08-09 09:07:49

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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Frequently Asked Questions

Who is the primary manufacturer of AFFLELOU?

The registered manufacturer of record for AFFLELOU is Starkey Laboratories, Inc..

What is the Primary UDI-DI identifier for AFFLELOU?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Incognito OM AI CROS RIC RT.

What classification code is assigned to this device?

This device is registered under product classification code KLW.

Similar Classification Devices (KLW)

Other Devices by Starkey Laboratories, Inc.

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