Regensight SRL
Active in EUDAMEDItalyfrom SRN EUDAMED SRN IT-MF-000026392
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Company details
- EUDAMED SRN
- IT-MF-000026392
- EU VAT number
- IT15376761001
- EUDAMED status
- Active
- EUDAMED registered name
- Regensight srl
- EUDAMED abbreviated name
- Regensight
- Registered address
- 3, Via Livenza, 00198, Rome, Italy
- Website
- www.regensight.com
- linkedin.com/company/regensight
- facebook.com/Regensight
- [email protected]
- PRRC contact
- Marco Lombardo
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 22 Dec 2029
Eurofins Product Testing Italy S.r.l. 0477 1 certificate
- EPT 0477.MDR.24/5691 Active
Quality management system EU MDR
- Issued
- 23 Dec 2024
- Expires
- 22 Dec 2029
TUV Rheinland Italia SRL 1936 1 certificate
- ITH 2265967 1 Active
Quality management system EU MDR
- Issued
- 30 Apr 2025
- Expires
- 29 Apr 2030
From the company website
We are the TECH Company the Theranostic Eye CareHealth Company We are pioneers of TERANOSTICA, our transformative technology to improve vision and quality of life to people with visual disturbances. CHI SIAMO MISSIONE Offer a non-invasive correction method of the most frequent visual disorders Technology Regensight introduced, first in the world, [...]
Frequently asked questions
How many devices does Regensight srl have in the registry?
The registry currently lists 3 devices for Regensight srl. Devices recorded under merged duplicate company entries are counted once.
Which registries list Regensight srl's devices?
Among its 3 most recently registered devices, Regensight srl has devices listed in EUDAMED (3 devices).
What risk classes do Regensight srl's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Regensight srl's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Regensight srl?
EUDAMED lists 2 certificates for Regensight srl (quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 30 Apr 2025.
What are the newest devices from Regensight srl in the registry?
The most recently registered devices listed for Regensight srl include DoRSight, C4V CHROMO4VIS and RitSight.