Neuro Event Labs Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED FDA SRN FI-MF-000024833 FEI 3022175264
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
Nelli (Version 7.11) Ref K251506
Regimes: CE MDD 510(k) Registry: 510(k)Nelli Ref 61288
Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- FI-MF-000024833
- FDA FEI number
- 3022175264
- EU VAT number
- FI27122841
- EUDAMED status
- Active
- EUDAMED registered name
- Neuro Event Labs Oy
- EUDAMED abbreviated name
- NEL
- Registered address
- 10, Biokatu, 33520, Tampere, Finland
- Website
- www.neuroeventlabs.com
- [email protected]
- Phone
- +358 50 345 5578
- PRRC contact
- Pierre Pelletier
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Dec 2029
Eurofins Electric & Electronics Finland Oy 0537 1 certificate
- CR-03-1233-860-24 Active
Quality management system EU MDR
- Issued
- 20 Mar 2026
- Expires
- 20 Dec 2029
- Reason
- Change approved
From the company website
<p>Video and audio recordings of the patient are captured via a Personal Recording Unit (PRU) with camera and microphone. <p>Nelli includes a web-based dashboard for viewing the analysis results. Relevant moments are identified by machine learning algorithms, resulting in an interactive report to be reviewed by the physician. In addition, Neuro Event Labs offers an optional service for expert review by credentialed clinical staff.</p>
Frequently asked questions
How many devices does Neuro Event Labs Oy have in the registry?
The registry currently lists 2 devices for Neuro Event Labs Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neuro Event Labs Oy's devices?
Among its 2 most recently registered devices, Neuro Event Labs Oy 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 Neuro Event Labs Oy's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Neuro Event Labs Oy's devices are Class I and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Neuro Event Labs Oy?
EUDAMED lists 1 certificate for Neuro Event Labs Oy (quality management system) under MDR. The most recent was issued on 20 Mar 2026.
What are the newest devices from Neuro Event Labs Oy in the registry?
The most recently registered devices listed for Neuro Event Labs Oy include Nelli (Version 7.11) and Nelli.