gudid Primary ID: SET uSpO2

Masimo SpO2 Module (UDI SET uSpO2)

Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Masimo SpO2 Module (Model/Catalog Number: SET uSpO2) is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. This product is indexed under FDA Product Code / Category Classification MSX within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: SET uSpO2
Product Code / EMDN: MSX
Device Name
Database Sync Date: 2026-08-09 09:11:05

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 Masimo SpO2 Module?

The registered manufacturer of record for Masimo SpO2 Module is Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the Primary UDI-DI identifier for Masimo SpO2 Module?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is SET uSpO2.

What classification code is assigned to this device?

This device is registered under product classification code MSX.

Similar Classification Devices (MSX)

Other Devices by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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