Retinsight GmbH
Active in EUDAMEDAustriafrom SRN EUDAMED SRN AT-MF-000009932
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
RetInSight Fluid Monitor Ref HEFM
RetInSight Fluid Monitor Ref TCFM
RetInSight GA Monitor Ref HEGM
Company details
- EUDAMED SRN
- AT-MF-000009932
- EU VAT number
- ATU75434004
- EUDAMED status
- Active
- EUDAMED registered name
- Retinsight GmbH
- Registered address
- 8, Universitätsring, 1010, Vienna, Austria
- Website
- retinsight.com
- [email protected]
- Phone
- +43 1 5813 881 203
- PRRC contact
- Nina Dusper
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 12 Dec 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 109030 0003 Reissued
Quality management system EU MDR
- Issued
- 12 Oct 2026
- Expires
- 12 Dec 2031
- Valid from
- 13 Dec 2026
From the company website
RetInSight develops MDR CE-certified AI solutions for OCT image analysis to support retinal disease monitoring in clinical routine and research.
What Retinsight GmbH makes
Retinsight GmbH manufactures medical devices for analyzing optical coherence tomography (OCT) images, including the RetInSight Fluid Monitor and RetInSight GA Monitor. These devices are designed to assist in the monitoring of retinal diseases by quantifying fluid accumulation and ganglion cell layer thickness in retinal scans.
The company’s devices fall under EU Device Class IIa and are registered in the EU’s eudamed database. Retinsight GmbH is based in Austria.
Frequently asked questions
How many devices does Retinsight GmbH have in the registry?
The registry currently lists 3 devices for Retinsight GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Retinsight GmbH's devices?
Among its 3 most recently registered devices, Retinsight GmbH has devices listed in EUDAMED (3 devices).
What risk classes do Retinsight GmbH's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Retinsight GmbH's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Retinsight GmbH?
EUDAMED lists 1 certificate for Retinsight GmbH (quality management system) under MDR. The most recent was issued on 2026-10-12.
What are the newest devices from Retinsight GmbH in the registry?
The most recently registered devices listed for Retinsight GmbH include RetInSight Fluid Monitor and RetInSight GA Monitor.