Medis Suite

Organization name

Medis Medical Imaging Systems bv

SRN

NL-MF-000002670

Manufacturer status

Active

Primary placement in Austria; available across 19 countries total.

Trade name

Medis Suite

UDI-DI code

MEDISSUITEXA2023

Basic UDI-DI

B-MEDISSUITEXA2023

Reference / catalog number

20240115

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Medis Suite XA is the gold-standard software solution for the quantification of coronary and peripheral vessels in X-ray angiograms. Further, it offers quantitative analyses for the left and right ventricles of the heart in X-ray angiograms. Medis Suite XA enables interventional cardiologists, interventional radiologists and researchers to obtain accurate results that help detect vessel abnormalities and cardiac (dys)function, assess the effectiveness of therapies and devices, and create evidence for treatment reimbursement. Medis Suite XA is used by clinicians, core laboratories and research institutions worldwide.

Additional information URL

https://www.medisimaging.com/

Clinical sizes

No clinical sizes registered for this device.

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

MEDISSUITEXA2023

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12050582CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES

Certificate health across this manufacturer's portfolio.