gudid Primary ID: REM Test tubes, 1.1mm (50 pcs.)

GN Otometrics A/S (UDI REM Test tubes, 1.1mm (50 pcs.))

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: REM Test tubes, 1.1mm (50 pcs.)) is a medical device manufactured by Natus Medical Denmark ApS. This product is indexed under FDA Product Code / Category Classification ETW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: REM Test tubes, 1.1mm (50 pcs.)
Product Code / EMDN: ETW
Device Name: REM Test tubes, 1.1mm (50 pcs.)
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 REM Test tubes, 1.1mm (50 pcs.).

What classification code is assigned to this device?

This device is registered under product classification code ETW.

Similar Classification Devices (ETW)

Other Devices by Natus Medical Denmark ApS

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