FIS&DM S.r.l.
Active in EUDAMEDItalyfrom SRN EUDAMED SRN IT-MF-000042292
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What FIS&DM S.r.l. makes
FIS&DM S.r.l. manufactures the Lysed, a device designed for blood lysing in laboratory settings, and SiloXide, a material used in medical or dental applications for oxide-based treatments or coatings. These products serve diagnostic and procedural needs in clinical environments.
The company’s portfolio is regulated under EU Medical Device Regulation as Class IIa devices and is listed in the EUDAMED database. The manufacturer is based in Italy.
Catalogue
Company details
- EUDAMED SRN
- IT-MF-000042292
- EU VAT number
- 01493940553
- EUDAMED status
- Active
- EUDAMED registered name
- FIS&DM S.r.l.
- Registered address
- 27/A, Strada di Sabbione, 05100, Terni, Italy
- Website
- www.fisindustry.it
- [email protected]
- Phone
- +39 0744 455503
- PRRC contact
- Paolo Rissone
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Jan 2030
ICIM S.P.A. 0425 1 certificate
- 0425-MDR-030117-00 Issued
Quality management system EU MDR
- Issued
- 21 Jan 2025
- Expires
- 20 Jan 2030
Frequently asked questions
How many devices does FIS&DM S.r.l. have in the registry?
The registry currently lists 3 devices for FIS&DM S.r.l.. Devices recorded under merged duplicate company entries are counted once.
Which registries list FIS&DM S.r.l.'s devices?
Among its 3 most recently registered devices, FIS&DM S.r.l. has devices listed in EUDAMED (3 devices).
What risk classes do FIS&DM S.r.l.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for FIS&DM S.r.l.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for FIS&DM S.r.l.?
EUDAMED lists 1 certificate for FIS&DM S.r.l. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-01-21.
What are the newest devices from FIS&DM S.r.l. in the registry?
The most recently registered devices listed for FIS&DM S.r.l. include Lysed and SiloXide.