Orla DTx Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED SRN FI-MF-000041810
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
- Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FI-MF-000041810
- EU VAT number
- FI31121745
- EUDAMED status
- Active
- EUDAMED registered name
- Orla DTx Oy
- EUDAMED abbreviated name
- Orla
- Registered address
- 21, Agricolantie, 07930, Pernaja, Finland
- Website
- orladtx.com/
- [email protected]
- PRRC contact
- Oskari Koskimies
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 5 Feb 2029
SGS FIMKO OY 0598 1 certificate
- FI26/00000015 Active
Quality management system EU MDR
- Issued
- 6 Feb 2026
- Expires
- 5 Feb 2029
From the company website
Orla DTx Oy announces that its Asthma Calculator software has been certified in accordance with the European Union Medical Device ...
Frequently asked questions
How many devices does Orla DTx Oy have in the registry?
The registry currently lists 1 device for Orla DTx Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orla DTx Oy's devices?
Among its 1 most recently registered device, Orla DTx Oy has devices listed in EUDAMED (1 device).
What risk classes do Orla DTx Oy's devices fall under?
Among its 1 most recently registered device, the classes recorded for Orla DTx Oy's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Orla DTx Oy?
EUDAMED lists 1 certificate for Orla DTx Oy (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 6 Feb 2026.
What are the newest devices from Orla DTx Oy in the registry?
The most recently registered devices listed for Orla DTx Oy include Asthma Calculator.