eudamed_udi
Primary ID: 08682549130442
Helix (UDI 08682549130442)
Manufactured by Ear Technic Hearing Aids
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Helix - Primary ID 08682549130442
Device Regulatory Overview
The Helix (Model/Catalog Number: 132-02310189) is a medical device manufactured by Ear Technic Hearing Aids. This product is indexed under FDA Product Code / Category Classification Y2145060201 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 132-02310189
- Product Code / EMDN
- Y2145060201
- Device Name
- TIE Family
- Database Sync Date
- 2026-08-09 16:30:41
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 Helix?
The registered manufacturer of record for Helix is Ear Technic Hearing Aids.
What is the Primary UDI-DI identifier for Helix?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08682549130442.
What classification code is assigned to this device?
This device is registered under product classification code Y2145060201.
Similar Classification Devices (Y2145060201)
Other Devices by Ear Technic Hearing Aids
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