Vitec Codea Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED SRN FI-MF-000012142
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Codea ePCR Ref Codea ePCR v1.2
Company details
- EUDAMED SRN
- FI-MF-000012142
- EU VAT number
- FI22390388
- EUDAMED status
- Active
- EUDAMED registered name
- Vitec Codea Oy
- Registered address
- 15 B 10, Hämeenkatu, 33100, Tampere, Finland
- Website
- www.vitec-codea.com/en
- fi.linkedin.com/company/codea-oy
- [email protected]
- Phone
- +358 400 470 707
- PRRC contact
- Jaakko Koljonen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 2 Sep 2027
SGS FIMKO OY 0598 1 certificate
- FI24/00000055 Amended
Quality management system EU MDR
- Issued
- 25 Nov 2024
- Expires
- 2 Sep 2027
- Reason
- Other
From the company website
Vitec Codea develops solutions for navigation, patient documentation, situational awareness and operational support – for services where the right information needs to be available when it matters.
What Vitec Codea Oy makes
Vitec Codea Oy manufactures the Codea ePCR, an electronic patient care record system designed for real-time clinical documentation and data management in healthcare settings. This software-based solution enables medical professionals to capture, store, and share patient information securely across different care environments, supporting workflow efficiency and continuity of care.
The Codea ePCR is classified as a Class IIa medical device under EU regulations and is listed in the EUDAMED database. The company is based in Finland and adheres to relevant regulatory requirements for electronic health record systems within the European Union.
Frequently asked questions
How many devices does Vitec Codea Oy have in the registry?
The registry currently lists 1 device for Vitec Codea Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vitec Codea Oy's devices?
Among its 1 most recently registered device, Vitec Codea Oy has devices listed in EUDAMED (1 device).
What risk classes do Vitec Codea Oy's devices fall under?
Among its 1 most recently registered device, the classes recorded for Vitec Codea Oy's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Vitec Codea Oy?
EUDAMED lists 1 certificate for Vitec Codea Oy (quality management system) under MDR. The most recent was issued on 2024-11-25.
What are the newest devices from Vitec Codea Oy in the registry?
The most recently registered devices listed for Vitec Codea Oy include Codea ePCR.