eudamed_udi
Primary ID: 07613389818253
scala S1-Dir R (UDI 07613389818253)
Manufactured by Sonova AG
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for scala S1-Dir R - Primary ID 07613389818253
Device Regulatory Overview
The scala S1-Dir R (Model/Catalog Number: 063-6392-0172) is a medical device manufactured by Sonova AG. This product is indexed under FDA Product Code / Category Classification Y2145060201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 063-6392-0172
- Product Code / EMDN
- Y2145060201
- Device Name
- Sonova ITE hearing aids
- Database Sync Date
- 2026-08-09 16:29:50
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 scala S1-Dir R?
The registered manufacturer of record for scala S1-Dir R is Sonova AG.
What is the Primary UDI-DI identifier for scala S1-Dir R?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 07613389818253.
What classification code is assigned to this device?
This device is registered under product classification code Y2145060201.
Similar Classification Devices (Y2145060201)
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