VIDEO BRONCHOSCOPES

Primary DI

03664977000097

Basic UDI-DI Code

3664977EMDNZ12020802SPPBD

Reference

10030001/20030001/30030000

Device Types

Sterile

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

The Broncoflex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni).

Broncoflex Agile & Broncoflex Vortex: This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni) and to be used with endotherapy accessories and instruments. The pulmonary tract include the organs, tissues and subsystems represented by the nasal passages, trachea and bronchial tree beyond the primary bronchi. The video-bronchoscope is inserted via the oral or nasal route. The Broncoflex should not be used for any purpose other than that described herein. Screeni: This product was developed by the company Axess Vision and is exclusively reserved for the endoscopic examinations claimed in the manual of the endoscope used (see list of compatible devices). The Screeni is used for viewing the lungs and airways by means of a single-use endoscope. The Screeni should not be used for any purpose other than that described herein.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).