eudamed_udi Primary ID: D-023297-9261-315-358W7

sino ITE V70 (UDI D-023297-9261-315-358W7)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The sino ITE V70 (Model/Catalog Number: 023297-9261-315-358) is a medical device manufactured by audifon GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification Y2145060201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 023297-9261-315-358
Product Code / EMDN: Y2145060201
Device Name: Hearing aid
Database Sync Date: 2026-08-09 16:29:54

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 sino ITE V70?

The registered manufacturer of record for sino ITE V70 is audifon GmbH & Co. KG.

What is the Primary UDI-DI identifier for sino ITE V70?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-023297-9261-315-358W7.

What classification code is assigned to this device?

This device is registered under product classification code Y2145060201.

Similar Classification Devices (Y2145060201)

Other Devices by audifon GmbH & Co. KG

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