EpiHeart Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED SRN FI-MF-000018287
- Devices
- 4
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What EpiHeart Oy makes
EpiHeart Oy manufactures accessories and equipment designed for cardiac tissue processing, including adapters for centrifuges, catheter systems for supernatant removal, and holders for transplant preparation. Their products are used in procedures involving heart tissue handling and preparation for transplantation.
The company’s devices are classified under EU Class I and are registered in the EUDAMED database. EpiHeart Oy is based in Finland and adheres to relevant regulatory requirements for these medical devices.
Catalogue
EpiHeart Adapter for Centrifuge Ref 66-000-002
Regimes: CE MDR Registry: EUDAMEDOperation Station Ref 62-000-002
Regimes: CE MDR Registry: EUDAMEDEpiHeart Catheter for supernatant removal Ref 60-000-002
Regimes: CE MDR Registry: EUDAMEDEpiHeart Transplant Holder Ref 64-000-002
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FI-MF-000018287
- EU VAT number
- FI31073851
- EUDAMED status
- Active
- EUDAMED registered name
- EpiHeart Oy
- EUDAMED abbreviated name
- EpiHeart
- Registered address
- 4, Haartmaninkatu, 00290, Helsinki, Finland
- Website
- www.epiheart.com
- linkedin.com/company/epiheart
- [email protected]
- Phone
- +358407516763
- PRRC contact
- Kai Kronström
From the company website
Innovative cardiac cell therapy treatment for heart failure administered during cardiac surgery.
Frequently asked questions
How many devices does EpiHeart Oy have in the registry?
The registry currently lists 4 devices for EpiHeart Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list EpiHeart Oy's devices?
Among its 4 most recently registered devices, EpiHeart Oy has devices listed in EUDAMED (4 devices).
What risk classes do EpiHeart Oy's devices fall under?
Among its 4 most recently registered devices, the classes recorded for EpiHeart Oy's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from EpiHeart Oy in the registry?
The most recently registered devices listed for EpiHeart Oy include EpiHeart Adapter for Centrifuge, Operation Station, EpiHeart Catheter for supernatant removal and EpiHeart Transplant Holder.