eudamed_udi
Primary ID: D-021957-002-8431-357KT
HE-S (UDI D-021957-002-8431-357KT)
Manufactured by audifon GmbH & Co. KG
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for HE-S - Primary ID D-021957-002-8431-357KT
Device Regulatory Overview
The HE-S (Model/Catalog Number: 021957-002-8431-357) is a medical device manufactured by audifon GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification Y214580 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 021957-002-8431-357
- Product Code / EMDN
- Y214580
- Device Name
- Receiver unit
- Database Sync Date
- 2026-08-09 16:29:44
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 HE-S?
The registered manufacturer of record for HE-S is audifon GmbH & Co. KG.
What is the Primary UDI-DI identifier for HE-S?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-021957-002-8431-357KT.
What classification code is assigned to this device?
This device is registered under product classification code Y214580.
Similar Classification Devices (Y214580)
Other Devices by audifon GmbH & Co. KG
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