Coala Solutions AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000046932
- Devices
- 1
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Coala Solutions AB makes
Coala Solutions AB manufactures the Coala Heart Monitor, a wearable device for continuous cardiac monitoring that uses P-wave-based analysis to detect atrial fibrillation. The system is designed for outpatient use and provides real-time results without traditional ECG electrodes or wires, intended for prescription-based patient monitoring in daily life.
The Coala Heart Monitor is classified as a Class IIa medical device and is registered in the EU’s eudamed database. The company is based in Sweden.
Catalogue
Coala Heart Monitor Ref Coala Monitor
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- SE-MF-000046932
- EU VAT number
- SE556248370001
- EUDAMED status
- Active
- EUDAMED registered name
- Coala Solutions AB
- Registered address
- 13, Bangårdsgatan, 75320, Uppsala, Sweden
- Website
- coalasolutions.com
- [email protected]
- Phone
- +46852516011
- PRRC contact
- Magnus Sorlander
From the company website
Coala Heart Monitor system is an award-winning medical device designed with a patient-first approach with instant analysis and results. No sticky ECG electrodes, itchy patches, or wires. Unique P-wave-based AF detection for maximum accuracy. A prescription-only solution to monitor patients in everyday life.
Frequently asked questions
How many devices does Coala Solutions AB have in the registry?
The registry currently lists 1 device for Coala Solutions AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Coala Solutions AB's devices?
Among its 1 most recently registered device, Coala Solutions AB has devices listed in EUDAMED (1 device).
What risk classes do Coala Solutions AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Coala Solutions AB's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from Coala Solutions AB in the registry?
The most recently registered devices listed for Coala Solutions AB include Coala Heart Monitor.