gudid
Primary ID: Smart One Oxi
MIR (UDI Smart One Oxi)
Manufactured by MIR MEDICAL INTERNATIONAL RESEARCH SPA
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MIR - Primary ID Smart One Oxi
Device Regulatory Overview
The MIR (Model/Catalog Number: Smart One Oxi) is a medical device manufactured by MIR MEDICAL INTERNATIONAL RESEARCH SPA. This product is indexed under FDA Product Code / Category Classification BZG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Smart One Oxi
- Product Code / EMDN
- BZG
- Device Name
- Smart Spirometer and Oximeter connected to an app available on a smart phone
- Database Sync Date
- 2026-08-09 09:04:32
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of MIR?
The registered manufacturer of record for MIR is MIR MEDICAL INTERNATIONAL RESEARCH SPA.
What is the Primary UDI-DI identifier for MIR?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Smart One Oxi.
What classification code is assigned to this device?
This device is registered under product classification code BZG.
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