gudid Primary ID: REM Probe Flex (2000-1)

Unity 4 / Measure (UDI REM Probe Flex (2000-1))

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Unity 4 / Measure (Model/Catalog Number: REM Probe Flex (2000-1)) is a medical device manufactured by Auditdata A/S. This product is indexed under FDA Product Code / Category Classification EWO within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: REM Probe Flex (2000-1)
Product Code / EMDN: EWO
Device Name: 2000-1 Fitting Unit Audiometer
Database Sync Date: 2026-08-09 09:12:44

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 Unity 4 / Measure?

The registered manufacturer of record for Unity 4 / Measure is Auditdata A/S.

What is the Primary UDI-DI identifier for Unity 4 / Measure?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is REM Probe Flex (2000-1).

What classification code is assigned to this device?

This device is registered under product classification code EWO.

Similar Classification Devices (EWO)

Other Devices by Auditdata A/S

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