N/A

Organization name

ArtiQ NV

SRN

BE-MF-000000314

Manufacturer status

Active

Primary placement in Belgium; available across 6 countries total.

Trade name

not provided

UDI-DI code

05419980057617

Basic UDI-DI

54199800576ArtiQ.PFT1HQ

Reference / catalog number

N/A

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The intended purpose of ArtiQ.Spiro is to provide automated interpretation of pulmonary function tests (PFTs) to assist clinicians 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.

Additional information URL

https://www.artiq.eu/instructions-for-use/

Clinical sizes

No clinical sizes registered for this device.

• R9099RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.