Casis Cardiac Simulation & Imaging Software
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000001813
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Casis Cardiac Simulation & Imaging Software makes
Casis Cardiac Simulation & Imaging Software develops the QIR Suite, a software tool for cardiac imaging and simulation used in pre-procedural planning and training. It integrates with imaging data to model coronary interventions, including stent placement and vessel visualization, supporting interventional cardiology workflows.
The QIR Suite is classified as a Class II medical device in the US and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Company details
- EUDAMED SRN
- FR-MF-000001813
- EU VAT number
- FR85820650935
- EUDAMED status
- Active
- EUDAMED registered name
- CASIS-CArdiac Simulation & Imaging Software
- EUDAMED abbreviated name
- CASIS
- Registered address
- 7, Impasse des Boussenots, 21800, Quetigny, France
- [email protected]
- Phone
- +33 3 73 27 51 20
- PRRC contact
- Jean-Joseph CHRISTOPHE
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 9 Jan 2030
GMED SAS 0459 1 certificate
- 40110 Active
Quality management system EU MDR
- Issued
- 7 Jul 2026
- Expires
- 9 Jan 2030
- Reason
- Other
Frequently asked questions
How many devices does Casis Cardiac Simulation & Imaging Software have in the registry?
The registry currently lists 2 devices for Casis Cardiac Simulation & Imaging Software. Devices recorded under merged duplicate company entries are counted once.
Which registries list Casis Cardiac Simulation & Imaging Software's devices?
Among its 2 most recently registered devices, Casis Cardiac Simulation & Imaging Software has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Casis Cardiac Simulation & Imaging Software's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Casis Cardiac Simulation & Imaging Software's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Casis Cardiac Simulation & Imaging Software?
EUDAMED lists 1 certificate for Casis Cardiac Simulation & Imaging Software (quality management system) under MDR. The most recent was issued on 7 Jul 2026.
What are the newest devices from Casis Cardiac Simulation & Imaging Software in the registry?
The most recently registered devices listed for Casis Cardiac Simulation & Imaging Software include QIR Suite.