PulseOn Oy
Active in EUDAMEDFinlandfrom SRN EUDAMED SRN FI-MF-000009325
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What PulseOn Oy makes
PulseOn Oy manufactures the PulseOn Arrhythmia Monitor System, a device designed for professional medical use to detect and analyze arrhythmias using optical heart rate technology.
The company’s device is classified as Class IIa under EU regulations and is listed in the eudamed database. PulseOn Oy is based in Finland.
Catalogue
PulseOn Arrhythmia Monitor System Ref AMS-1
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- FI-MF-000009325
- EU VAT number
- FI25089865
- EUDAMED status
- Active
- EUDAMED registered name
- PulseOn Oy
- Registered address
- 12, Tekniikantie, 02150, Espoo, Finland
- Website
- pulseon.com/
- [email protected]
- PRRC contact
- Olli-Pekka Ruuskanen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 25 Feb 2027
Eurofins Electric & Electronics Finland Oy 0537 1 certificate
- CR-03-1224-781-22 Expiring
Quality management system EU MDR
- Issued
- 24 Feb 2022
- Expires
- 25 Feb 2027
- Valid from
- 25 Feb 2022
From the company website
PulseOn, a pioneer in optical heart rate (OHR) technology, is a high tech company specialized in arrhythmia detection devices and analysis software for professional medical use.
Frequently asked questions
How many devices does PulseOn Oy have in the registry?
The registry currently lists 1 device for PulseOn Oy. Devices recorded under merged duplicate company entries are counted once.
Which registries list PulseOn Oy's devices?
Among its 1 most recently registered device, PulseOn Oy has devices listed in EUDAMED (1 device).
What risk classes do PulseOn Oy's devices fall under?
Among its 1 most recently registered device, the classes recorded for PulseOn Oy's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for PulseOn Oy?
EUDAMED lists 1 certificate for PulseOn Oy (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 24 Feb 2022.
What are the newest devices from PulseOn Oy in the registry?
The most recently registered devices listed for PulseOn Oy include PulseOn Arrhythmia Monitor System.