gudid Primary ID: Starkey Omega AI 20 HS R

STARKEY (UDI Starkey Omega AI 20 HS R)

Manufactured by Starkey Laboratories, Inc.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The STARKEY (Model/Catalog Number: Starkey Omega AI 20 HS R) 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: Starkey Omega AI 20 HS R
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 STARKEY?

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

What is the Primary UDI-DI identifier for STARKEY?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Starkey Omega AI 20 HS R.

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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