gudid Primary ID: U4 YOUNG NEUTRAL

EQULIBRATORE U4 YOUNG (UDI U4 YOUNG NEUTRAL)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The EQULIBRATORE U4 YOUNG (Model/Catalog Number: U4 YOUNG NEUTRAL) is a medical device manufactured by EPTAMED SRL. This product is indexed under FDA Product Code / Category Classification KMY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: U4 YOUNG NEUTRAL
Product Code / EMDN: KMY
Device Name: Preformed orthodontic tooth positioner
Database Sync Date: 2026-08-09 09:00:28

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 EQULIBRATORE U4 YOUNG?

The registered manufacturer of record for EQULIBRATORE U4 YOUNG is EPTAMED SRL.

What is the Primary UDI-DI identifier for EQULIBRATORE U4 YOUNG?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is U4 YOUNG NEUTRAL.

What classification code is assigned to this device?

This device is registered under product classification code KMY.

Similar Classification Devices (KMY)

Other Devices by EPTAMED SRL

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