EUROLyser Diagnostica GmbH
Active in EUDAMEDAustriafrom SRN EUDAMED SRN AT-MF-000013746
- Devices
- 26
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What EUROLyser Diagnostica GmbH makes
EUROLyser Diagnostica GmbH produces in-vitro diagnostic (IVD) test kits and analysers for clinical and veterinary use, including quantitative and qualitative assays for biomarkers such as D-Dimer, ferritin, HbA1c, troponin I, CRP, cystatin C, and hsCRP. Their portfolio also includes collection devices like the iFOB kit for faecal occult blood testing and control kits for calibration purposes, as well as automated analysers like the CUBE-S for high-throughput testing.
The company’s products fall under EU IVD device classifications, primarily Class A and IVD General, and are registered in the EU’s eudamed database. Headquartered in Austria, their devices are designed for laboratory and point-of-care use, adhering to EU regulatory requirements for in-vitro diagnostics.
Catalogue
Search and filter all 26 devicesCompany details
- EUDAMED SRN
- AT-MF-000013746
- EU VAT number
- ATU61454713
- EUDAMED status
- Active
- EUDAMED registered name
- EUROLyser Diagnostica GmbH
- EUDAMED abbreviated name
- EUROLyser
- Registered address
- 8a, Gewerbehofstrasse, 5023, Salzburg, Austria
- Website
- www.eurolyser.com
- [email protected]
- Phone
- +43 662 432100
- PRRC contact
- Jürgen Berlanda
From the company website
EUROLyser presents its next new parameter for the measurement of beta-Hydroxybutyrate. This test provides reliable, precise and immediate results for veterinarians. The Parameter beta-Hydroxybutyrate (BHB) is one of three main ketone bodies that the liver produces …
Frequently asked questions
How many devices does EUROLyser Diagnostica GmbH have in the registry?
The registry currently lists 26 devices for EUROLyser Diagnostica GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list EUROLyser Diagnostica GmbH's devices?
Among its 26 most recently registered devices, EUROLyser Diagnostica GmbH has devices listed in EUDAMED (26 devices).
What risk classes do EUROLyser Diagnostica GmbH's devices fall under?
Among its 26 most recently registered devices, the classes recorded for EUROLyser Diagnostica GmbH's devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from EUROLyser Diagnostica GmbH in the registry?
The most recently registered devices listed for EUROLyser Diagnostica GmbH include D-Dimer test kit (16 tests), Ferritin control kit, Ferritin test kit (32 tests) and HbA1c test kit (24 tests).