GUDIDData
eudamed_udi Primary ID: 00842318187147

STARKEY EVOLV AI 2400 IIC NW (UDI 00842318187147)

Manufactured by Starkey Laboratories Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for STARKEY EVOLV AI 2400 IIC NW - Primary ID 00842318187147

Device Regulatory Overview

The STARKEY EVOLV AI 2400 IIC NW (Model/Catalog Number: 63327-SHT) is a medical device manufactured by Starkey Laboratories Inc.. This product is indexed under FDA Product Code / Category Classification Y2145060204 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
63327-SHT
Product Code / EMDN
Y2145060204
Device Name
Evolv AI
Database Sync Date
2026-08-09 16:29:09

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 STARKEY EVOLV AI 2400 IIC NW?

The registered manufacturer of record for STARKEY EVOLV AI 2400 IIC NW is Starkey Laboratories Inc..

What is the Primary UDI-DI identifier for STARKEY EVOLV AI 2400 IIC NW?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00842318187147.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060204.

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