GUDIDData
gudid Primary ID: RT-6100

SavEar (UDI RT-6100)

Manufactured by SUNMED, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SavEar - Primary ID RT-6100

Device Regulatory Overview

The SavEar (Model/Catalog Number: RT-6100) is a medical device manufactured by SUNMED, LLC. This product is indexed under FDA Product Code / Category Classification JAY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
RT-6100
Product Code / EMDN
JAY
Device Name
SavEar Head Band
Database Sync Date
2026-08-09 09:04:13

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 SavEar?

The registered manufacturer of record for SavEar is SUNMED, LLC.

What is the Primary UDI-DI identifier for SavEar?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is RT-6100.

What classification code is assigned to this device?

This device is registered under product classification code JAY.

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