Zenicor Medical Systems AB
Sweden Last updated 21 Oct 2026
- Devices
- 2
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Zenicor One Ref Zenicor EKG-2
EUDAMED certificates
Intertek Medical Notified Body AB 2862 1 certificate
- 28620139751 Issued
Quality management system EU MDR
- Issued
- 17 Jan 2023
- Expires
- 6 May 2027
Related companies
Notified bodies
About
Zenicor Medical Systems AB is a Swedish medical technology company that is a leader in early diagnosis of arrhythmias and stroke prevention for healthcare. The company was founded in 2003 and has thus been active in the area for 20 years, which means that we are one of the pioneers leading the developments in the diagnostics of atrial fibrillation.
What Zenicor Medical Systems AB makes
Zenicor Medical Systems AB manufactures diagnostic equipment designed for the detection of arrhythmias and the prevention of stroke. Their product portfolio includes the Zenicor One and Zenicor View systems.
These devices are classified as Class IIa medical devices. The company is based in Sweden, and their products are listed in the EUDAMED database.
Frequently asked questions
What types of medical devices does Zenicor Medical Systems AB manufacture?
Zenicor Medical Systems AB manufactures diagnostic equipment specifically designed for the detection of arrhythmias and the prevention of stroke. Their current product portfolio includes the Zenicor One and Zenicor View systems, which are developed to support healthcare providers in early diagnostic processes.
Where is Zenicor Medical Systems AB based?
Zenicor Medical Systems AB is based in Sweden. This location is the primary site for the company's operations as a medical technology developer focused on diagnostic solutions for cardiac health.
How are the devices from Zenicor Medical Systems AB classified?
The devices manufactured by Zenicor Medical Systems AB, such as the Zenicor One and Zenicor View, are classified as Class IIa medical devices. This classification is based on the regulatory framework applied to their diagnostic equipment for arrhythmia detection.
Where can I find information regarding the registration of these devices?
Information regarding the devices produced by Zenicor Medical Systems AB is available through the EUDAMED database. This registry is the official platform where their medical devices are listed for regulatory transparency.
Information
- Address
- 8, Saltmätargatan, Stockholm, Sweden
- Website
- www.zenicor.se
- [email protected]
- Phone
- +4684426860
- PRRC contact
- Liz Muwanga
- EUDAMED SRN
- SE-MF-000014176