GUDIDData
gudid Primary ID: ICON

CARDIOTRONIC (UDI ICON)

Manufactured by Osypka Medical GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CARDIOTRONIC - Primary ID ICON

Device Regulatory Overview

The CARDIOTRONIC (Model/Catalog Number: ICON) is a medical device manufactured by Osypka Medical GmbH. This product is indexed under FDA Product Code / Category Classification DSB within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
ICON
Product Code / EMDN
DSB
Device Name
ICON Non-invasive Hemodynamic Cardiometer
Database Sync Date
2026-08-09 09:53:22

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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Frequently Asked Questions

Who is the primary manufacturer of CARDIOTRONIC?

The registered manufacturer of record for CARDIOTRONIC is Osypka Medical GmbH.

What is the Primary UDI-DI identifier for CARDIOTRONIC?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ICON.

What classification code is assigned to this device?

This device is registered under product classification code DSB.

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