eudamed_udi Primary ID: 05714880197846

HA SP 380 BG (UDI 05714880197846)

Manufactured by WSAUD A/S

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The HA SP 380 BG (Model/Catalog Number: 21025930) is a medical device manufactured by WSAUD A/S. This product is indexed under FDA Product Code / Category Classification Y2145060101 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 21025930
Product Code / EMDN: Y2145060101
Device Name: BTE
Database Sync Date: 2026-08-09 16:28:47

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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Frequently Asked Questions

Who is the primary manufacturer of HA SP 380 BG?

The registered manufacturer of record for HA SP 380 BG is WSAUD A/S.

What is the Primary UDI-DI identifier for HA SP 380 BG?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05714880197846.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060101.

Similar Classification Devices (Y2145060101)

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