gudid
Primary ID: Q-Box
COSMED (UDI Q-Box)
Manufactured by C O S M E D SRL
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for COSMED - Primary ID Q-Box
Device Regulatory Overview
The COSMED (Model/Catalog Number: Q-Box) is a medical device manufactured by C O S M E D SRL. This product is indexed under FDA Product Code / Category Classification BTY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Q-Box
- Product Code / EMDN
- BTY
- Device Name
- The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry, Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardio-pulmonary disease conditions.
- Database Sync Date
- 2026-08-09 09:21:50
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 COSMED?
The registered manufacturer of record for COSMED is C O S M E D SRL.
What is the Primary UDI-DI identifier for COSMED?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Q-Box.
What classification code is assigned to this device?
This device is registered under product classification code BTY.
Similar Classification Devices (BTY)
Other Devices by C O S M E D SRL
Programmatic Export
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