eudamed_udi
Primary ID: 00840388219621
SOUNDGEAR AMP 2 ITE R (UDI 00840388219621)
Manufactured by Starkey Laboratories Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SOUNDGEAR AMP 2 ITE R - Primary ID 00840388219621
Device Regulatory Overview
The SOUNDGEAR AMP 2 ITE R (Model/Catalog Number: 72182-SDG) 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
- 72182-SDG
- Product Code / EMDN
- Y2145060201
- Device Name
- Omega AI Custom
- Database Sync Date
- 2026-08-09 16:46:45
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 SOUNDGEAR AMP 2 ITE R?
The registered manufacturer of record for SOUNDGEAR AMP 2 ITE R is Starkey Laboratories Inc..
What is the Primary UDI-DI identifier for SOUNDGEAR AMP 2 ITE R?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00840388219621.
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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