gudid Primary ID: "Headset ME70 (8 kHz) matched

GN Otometrics A/S (UDI "Headset ME70 (8 kHz) matched)

Manufactured by Natus Medical Denmark ApS

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

Scannable UDI-DI Representation

Device Regulatory Overview

The GN Otometrics A/S (Model/Catalog Number: "Headset ME70 (8 kHz) matched) is a medical device manufactured by Natus Medical Denmark ApS. This product is indexed under FDA Product Code / Category Classification ETY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: "Headset ME70 (8 kHz) matched
Product Code / EMDN: ETY
Device Name
Database Sync Date: 2026-08-09 09:12:40

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 GN Otometrics A/S?

The registered manufacturer of record for GN Otometrics A/S is Natus Medical Denmark ApS.

What is the Primary UDI-DI identifier for GN Otometrics A/S?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is "Headset ME70 (8 kHz) matched.

What classification code is assigned to this device?

This device is registered under product classification code ETY.

Similar Classification Devices (ETY)

Other Devices by Natus Medical Denmark ApS

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