Hemolens Diagnostics Sp. z o.o.
Active in EUDAMEDPolandfrom SRN EUDAMED SRN PL-MF-000016015
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
- CE MDR EUDAMED
Company details
- EUDAMED SRN
- PL-MF-000016015
- EU VAT number
- PL5213714387
- EUDAMED status
- Active
- EUDAMED registered name
- Hemolens Diagnostics Sp. z o.o.
- Registered address
- 48G, Legnicka, 54-202, Wrocław, Poland
- Website
- www.hemolens.com
- linkedin.com/company/13015779
- facebook.com/HemolensDiagnostics
- [email protected]
- Phone
- (+44) 744 314 81 50
- PRRC contact
- Marta Uchmanowicz
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 May 2031
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2709727-1 Issued
Quality management system EU MDR
- Issued
- 21 May 2026
- Expires
- 20 May 2031
From the company website
With FFR-CT, Hemolens Diagnostics offers a promising new technology to detect anatomically and functionally significant coronary artery stenosis on the basis of non-invasive examinations: coronary computed tomography angiography (CCTA) and continuous non-invasive blood pressure (CNBP) monitoring. Methods based on measuring fractional flow reserve (FFR) from computed tomography scans of coronary arteries are recommended by international scientific associations.
Frequently asked questions
How many devices does Hemolens Diagnostics Sp. z o.o. have in the registry?
The registry currently lists 1 device for Hemolens Diagnostics Sp. z o.o.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemolens Diagnostics Sp. z o.o.'s devices?
Among its 1 most recently registered device, Hemolens Diagnostics Sp. z o.o. has devices listed in EUDAMED (1 device).
What risk classes do Hemolens Diagnostics Sp. z o.o.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hemolens Diagnostics Sp. z o.o.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Hemolens Diagnostics Sp. z o.o.?
EUDAMED lists 1 certificate for Hemolens Diagnostics Sp. z o.o. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-05-21.
What are the newest devices from Hemolens Diagnostics Sp. z o.o. in the registry?
The most recently registered devices listed for Hemolens Diagnostics Sp. z o.o. include Cardiolens Viewer.