gudid
Primary ID: MetaLyzer3B
CORTEX CPET System (UDI MetaLyzer3B)
Manufactured by Cortex Biophysik GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CORTEX CPET System - Primary ID MetaLyzer3B
Device Regulatory Overview
The CORTEX CPET System (Model/Catalog Number: MetaLyzer3B) is a medical device manufactured by Cortex Biophysik GmbH. This product is indexed under FDA Product Code / Category Classification BTY within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- MetaLyzer3B
- Product Code / EMDN
- BTY
- Device Name
- The CORTEX CPET systems are intended for use in CPET, Spirometric, and Basal-/Resting Metabolic Rate Tests for the purpose to objectify the ventilatory, cardio-circulatory and metabolic capacity. With the following indications, they support the user in finding or confirming diagnoses, determining therapy programs and monitoring therapies.In a CPET test, a patient undergoes a period of defined physical stress (normally 10-20 minutes). Hereby data is measured about ventilation, gas exchange and heart rate. On basis of these measured data, further data is calculated and displayed, in order to depict the performance of the cardio-respiratory system.In a spirometry test, the patient performs defined breathing maneuvers (VC, FVC, MVV). Thereby measurement data of the respiratory strength and volume is collected and displayed, in order to show the mechanical capacity of the respiratory system.In a Basal-/Resting Metabolic Rate Test the patient performs a rest test (normally 15-20 minutes). Thereby measurement data of the gas exchange is collected and displayed, in order to estimate the Basal-/Resting Metabolic Rate.
- Database Sync Date
- 2026-08-09 09:16:45
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 CORTEX CPET System?
The registered manufacturer of record for CORTEX CPET System is Cortex Biophysik GmbH.
What is the Primary UDI-DI identifier for CORTEX CPET System?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MetaLyzer3B.
What classification code is assigned to this device?
This device is registered under product classification code BTY.
Similar Classification Devices (BTY)
Other Devices by Cortex Biophysik GmbH
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