eudamed_udi Primary ID: 08436035520893

Sibelsound 400 AM (UDI 08436035520893)

Manufactured by SIBEL SAU

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Sibelsound 400 AM (Model/Catalog Number: 01379) is a medical device manufactured by SIBEL SAU. This product is indexed under FDA Product Code / Category Classification Z121401 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 01379
Product Code / EMDN: Z121401
Device Name: Sibelsound 400
Database Sync Date: 2026-08-09 17:17:58

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 Sibelsound 400 AM?

The registered manufacturer of record for Sibelsound 400 AM is SIBEL SAU.

What is the Primary UDI-DI identifier for Sibelsound 400 AM?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08436035520893.

What classification code is assigned to this device?

This device is registered under product classification code Z121401.

Similar Classification Devices (Z121401)

Other Devices by SIBEL SAU

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