gudid
Primary ID: Quark C12x
COSMED (UDI Quark C12x)
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 Quark C12x
Device Regulatory Overview
The COSMED (Model/Catalog Number: Quark C12x) is a medical device manufactured by C O S M E D SRL. This product is indexed under FDA Product Code / Category Classification MWI within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Quark C12x
- Product Code / EMDN
- MWI
- Device Name
- The Quark C12x is a System for ECG and Stress Electrocardiography testing. ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients.
- 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 Quark C12x.
What classification code is assigned to this device?
This device is registered under product classification code MWI.
Similar Classification Devices (MWI)
Other Devices by C O S M E D SRL
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