STARKEY EVOLV AI 1200 ITE R (UDI 00842318186461)
Manufactured by Starkey Laboratories Inc.
Device Regulatory Overview
The STARKEY EVOLV AI 1200 ITE R (Model/Catalog Number: 63299-SHT) 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
- 63299-SHT
- Product Code / EMDN
- Y2145060201
- Device Name
- Evolv AI
- Database Sync Date
- 2026-08-09 16:28:46
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of STARKEY EVOLV AI 1200 ITE R?
The registered manufacturer of record for STARKEY EVOLV AI 1200 ITE R is Starkey Laboratories Inc..
What is the Primary UDI-DI identifier for STARKEY EVOLV AI 1200 ITE R?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00842318186461.
What classification code is assigned to this device?
This device is registered under product classification code Y2145060201.
Similar Classification Devices (Y2145060201)
Other Devices by Starkey Laboratories Inc.
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