Firalis SA
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000035853
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Firalis SA makes
Firalis SA manufactures the APO-Easy Genotyping kit, a diagnostic test designed for genetic analysis of the APOE gene variants, commonly used in cardiovascular risk assessment and Alzheimer’s disease research.
The APO-Easy Genotyping kit is classified as a Class II medical device under FDA regulations and is authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
APO-Easy® genotyping kit Ref FLS-OE-02
Regimes: CE IVDR Registry: EUDAMEDAPO-Easy Genotyping kit Ref DEN240032
Regimes: De Novo Registry: 510(k)
Company details
- EUDAMED SRN
- FR-MF-000035853
- EU VAT number
- FR12504944364
- EUDAMED status
- Active
- EUDAMED registered name
- Firalis SA
- EUDAMED abbreviated name
- Fir
- Registered address
- 35, Rue du Fort, 68330, Huningue, France
- [email protected]
- Phone
- +33389911320
- PRRC contact
- Joanna Michel
Frequently asked questions
How many devices does Firalis SA have in the registry?
The registry currently lists 2 devices for Firalis SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Firalis SA's devices?
Among its 2 most recently registered devices, Firalis SA 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 Firalis SA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Firalis SA's devices are Class II and IVDR Class C. Each device page shows its own class and authorisation.
What are the newest devices from Firalis SA in the registry?
The most recently registered devices listed for Firalis SA include APO-Easy® genotyping kit and APO-Easy Genotyping kit.