gudid Primary ID: Aurora Bi-Level S/T

Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level (UDI Aurora Bi-Level S/T)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level (Model/Catalog Number: Aurora Bi-Level S/T) is a medical device manufactured by SYSMED (CHINA) CO.,LTD. This product is indexed under FDA Product Code / Category Classification BZD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: Aurora Bi-Level S/T
Product Code / EMDN: BZD
Device Name
Database Sync Date: 2026-08-09 09:05:25

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 Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level?

The registered manufacturer of record for Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level is SYSMED (CHINA) CO.,LTD.

What is the Primary UDI-DI identifier for Non-invasive Ventilator(Continuous Positive Airway Pressure Units, Bi-Level?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Aurora Bi-Level S/T.

What classification code is assigned to this device?

This device is registered under product classification code BZD.

Similar Classification Devices (BZD)

Other Devices by SYSMED (CHINA) CO.,LTD

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