GUDIDData
gudid Primary ID: K4b2

COSMED (UDI K4b2)

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 K4b2

Device Regulatory Overview

The COSMED (Model/Catalog Number: K4b2) is a medical device manufactured by C O S M E D SRL. This product is indexed under FDA Product Code / Category Classification BZC within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
K4b2
Product Code / EMDN
BZC
Device Name
The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4b2 measures, in real conditions, the ventilation, the O2 consumption the CO2 production and the heart rate of the person being monitored.
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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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 K4b2.

What classification code is assigned to this device?

This device is registered under product classification code BZC.

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