gudid
Primary ID: NIOX VERO Test Kit 1000
NIOX (UDI NIOX VERO Test Kit 1000)
Manufactured by Circassia AB
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NIOX - Primary ID NIOX VERO Test Kit 1000
Device Regulatory Overview
The NIOX (Model/Catalog Number: NIOX VERO Test Kit 1000) is a medical device manufactured by Circassia AB. This product is indexed under FDA Product Code / Category Classification MXA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- NIOX VERO Test Kit 1000
- Product Code / EMDN
- MXA
- Device Name
- Contains one sensor preprogrammed for a defined number of tests that is placed in the NIOX VERO device to enable a set amount of tests to be performed (1000). Also contains sufficient disposable patient filters (non-sterile) to be able to perform testing for each patient.
- Database Sync Date
- 2026-08-09 09:48:57
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of NIOX?
The registered manufacturer of record for NIOX is Circassia AB.
What is the Primary UDI-DI identifier for NIOX?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is NIOX VERO Test Kit 1000.
What classification code is assigned to this device?
This device is registered under product classification code MXA.
Similar Classification Devices (MXA)
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