DigiFinland Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED SRN FI-MF-000002451
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 2 in force. 1 certificate has expired.
Market reach
- European Union
- EUDAMED actor, 2 certificates
What DigiFinland Oy makes
DigiFinland Oy develops digital health services, including a platform called Omaolo for managing and monitoring patient data, as well as a navigation service called Navigaattoripalvelu for guiding users through healthcare processes. These tools are designed to facilitate remote patient engagement and streamline access to medical information and services.
The company’s products fall under EU medical device classifications of Class IIa and Class IIb, and they are registered in the EU’s eudamed database. DigiFinland Oy is based in Finland.
Catalogue
Navigaattoripalvelu Ref Navi01
Regimes: CE MDR Registry: EUDAMEDOmaolo Ref Oma02
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FI-MF-000002451
- EU VAT number
- FI28593557
- EUDAMED status
- Active
- EUDAMED registered name
- DigiFinland Oy
- Registered address
- 8-10, Siltasaarenkatu 8–10, 00530, Helsinki, Finland
- Website
- www.digifinland.fi
- [email protected]
- PRRC contact
- Juha Eerola
EUDAMED certificates
2 certificates1 valid, 1 expiredMDR 2next expiry 15 May 2028
SGS FIMKO OY 0598 2 certificates
- FI22/871876 Active
Quality management system EU MDR
- Issued
- 2 Sep 2026
- Expires
- 15 May 2028
- Valid from
- 3 Sep 2026
- Reason
- Add device or group
- FI22/871876 Expired
Quality management system EU MDR
- Issued
- 19 Dec 2024
- Expires
- 15 May 2025
- Reason
- Add device or group
Frequently asked questions
How many devices does DigiFinland Oy have in the registry?
The registry currently lists 2 devices for DigiFinland Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list DigiFinland Oy's devices?
Among its 2 most recently registered devices, DigiFinland Oy has devices listed in EUDAMED (2 devices).
What risk classes do DigiFinland Oy's devices fall under?
Among its 2 most recently registered devices, the classes recorded for DigiFinland Oy's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for DigiFinland Oy?
EUDAMED lists 2 certificates for DigiFinland Oy (quality management system) under MDR. The most recent was issued on 2026-09-02.
What are the newest devices from DigiFinland Oy in the registry?
The most recently registered devices listed for DigiFinland Oy include Navigaattoripalvelu and Omaolo.