Medinice S.A.
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000026941
- Devices
- 3
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Medinice S.A. makes
Medinice S.A. manufactures cryoablation devices for cardiac procedures, including the CoolCryo cryoapplicator and its control console with liquid nitrogen reservoir. It also produces the PacePress compression device, designed for implant site management during cardiac implantable electronic device (CIED) procedures.
The company’s devices are classified as Class II and Class IIa under EU and US regulations, with listings in the EUDAMED registry and FDA’s 510(k) database. Medinice S.A. is based in Poland.
Catalogue
Company details
- EUDAMED SRN
- PL-MF-000026941
- EU VAT number
- 6631868308
- EUDAMED status
- Active
- EUDAMED registered name
- Medinice S.A.
- EUDAMED abbreviated name
- Medinice
- Registered address
- 2, Hankiewicza, 02103, Warszawa, Poland
- Website
- www.medinice.pl/
- linkedin.com/company/medinice.pl
- [email protected]
- Phone
- +48 725 500 051
- PRRC contact
- Grzegorz Wróblewski
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 23 Feb 2030
TUV NORD Polska Sp. z o.o 2274 1 certificate
- TNP/MDR/0032/5013/2025 Issued
Quality management system EU MDR
- Issued
- 24 Feb 2025
- Expires
- 23 Feb 2030
From the company website
Medinice completed the CoolCryo clinical investigation and 6-month patient follow-up, with all participants in good health. Results confirmed the device’s safety and support further MDR regulatory work, CE marking and commercialization in Europe.
Frequently asked questions
How many devices does Medinice S.A. have in the registry?
The registry currently lists 3 devices for Medinice S.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medinice S.A.'s devices?
Among its 3 most recently registered devices, Medinice S.A. has devices listed in EUDAMED (2 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medinice S.A.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Medinice S.A.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Medinice S.A.?
EUDAMED lists 1 certificate for Medinice S.A. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-02-24.
What are the newest devices from Medinice S.A. in the registry?
The most recently registered devices listed for Medinice S.A. include CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) and PacePress.