PORTALED (UDI R00)

Manufactured by Ecleris

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

Scannable UDI-DI Representation

Device Regulatory Overview

The PORTALED (Model/Catalog Number: R00) is a medical device manufactured by Ecleris. This product is indexed under FDA Product Code / Category Classification KYT within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R00
Product Code / EMDN: KYT
Device Name: LED LIGHT SOURCE
Database Sync Date: 2026-08-09 09:18:01

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 PORTALED?

The registered manufacturer of record for PORTALED is Ecleris.

What is the Primary UDI-DI identifier for PORTALED?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R00.

What classification code is assigned to this device?

This device is registered under product classification code KYT.

Similar Classification Devices (KYT)

Other Devices by Ecleris

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