GUDIDData
gudid Primary ID: 5.016

Vivos mmRNA (UDI 5.016)

Manufactured by Aurum Group Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Vivos mmRNA - Primary ID 5.016

Device Regulatory Overview

The Vivos mmRNA (Model/Catalog Number: 5.016) is a medical device manufactured by Aurum Group Ltd. This product is indexed under FDA Product Code / Category Classification LRK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
5.016
Product Code / EMDN
LRK
Device Name
The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep. The device is customized to each patient and features an adjustment mechanism (expansion screw) to allow it to be further customized to each patient.
Database Sync Date
2026-08-09 09:09:51

Full Regulatory Attributes

🔒 Token Gated
{
    "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 Vivos mmRNA?

The registered manufacturer of record for Vivos mmRNA is Aurum Group Ltd.

What is the Primary UDI-DI identifier for Vivos mmRNA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5.016.

What classification code is assigned to this device?

This device is registered under product classification code LRK.

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