gudid Primary ID: uMI 550

uMI (UDI uMI 550)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The uMI (Model/Catalog Number: uMI 550) is a medical device manufactured by UIH TECHNOLOGIES LLC. This product is indexed under FDA Product Code / Category Classification KPS within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: uMI 550
Product Code / EMDN: KPS
Device Name: The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals.
Database Sync Date: 2026-08-09 09:06:43

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 uMI?

The registered manufacturer of record for uMI is UIH TECHNOLOGIES LLC.

What is the Primary UDI-DI identifier for uMI?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is uMI 550.

What classification code is assigned to this device?

This device is registered under product classification code KPS.

Similar Classification Devices (KPS)

Other Devices by UIH TECHNOLOGIES LLC

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