Eu Mdr Eu Md Class 2a On The Market 🇧🇪 Belgium

ArtiQ.Spiro

ArtiQ NV · 🇧🇪 Belgium
Devices (same UDI-DI)
2
Certificates
0
Countries
4
Notified Bodies
0

Basic Information

Primary DI
05419980057617
Basic UDI-DI Code
54199800576ArtiQ.PFT1HQ
Reference
N/A
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
ArtiQ NV

Additional Description

The intended purpose of ArtiQ.Spiro is to provide automated interpretation of pulmonary function tests (PFTs) to assist physicians in the diagnosis and follow-up of respiratory diseases. It is a software as medical device with no graphical user interface that can be used through an application programming interface (API) for the generation of ArtiQ.Spiro reports. These reports are meant to supplement, and by no means substitute, any initial report(s) generated by PFT devices, and are not meant to be used as a replacement of the medical practitioner's interpretation.

CND Nomenclature Codes

Code Description
R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

Available In Countries

🇧🇪 Belgium 🇩🇪 Germany 🇫🇷 France 🇬🇧 United Kingdom

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