Custom Software & Electronics, S.l
Active in EUDAMEDSpainfrom SRN EUDAMED SRN ES-MF-000003031
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Custom Software & Electronics, S.l makes
The company develops wireless electrocardiograph devices capable of recording 12-lead ECG data, designed for clinical use in cardiac diagnostics.
These devices are classified as Class IIa under EU regulations and are listed in the eudamed database. The manufacturer is based in Spain.
Catalogue
Medicalcse Ref ECG-EXPERT
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- ES-MF-000003031
- EU VAT number
- B63010524
- EUDAMED status
- Active
- EUDAMED registered name
- CUSTOM SOFTWARE & ELECTRONICS, S.L
- Registered address
- 167, Sant Antoni Maria Claret,, 08025, BARCELONA, Spain
- Website
- www.medicalcse.com
- linkedin.com/company/medicalcse
- [email protected]
- Phone
- +34 722 613 269
- PRRC contact
- DOMENECH RAMON
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Apr 2031
CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS 0318 1 certificate
- 2026 CR 0083 Active
Quality management system EU MDR
- Issued
- 17 Apr 2026
- Expires
- 16 Apr 2031
From the company website
ECG-Expert: 12-derivative wireless electrocardiographer, MDR Class IIa, with Dr. Josep Brugada as Medical Advisor. Done in Barcelona by MedicalCSE.
Frequently asked questions
How many devices does CUSTOM SOFTWARE & ELECTRONICS, S.L have in the registry?
The registry currently lists 1 device for CUSTOM SOFTWARE & ELECTRONICS, S.L. Devices recorded under merged duplicate company entries are counted once.
Which registries list CUSTOM SOFTWARE & ELECTRONICS, S.L's devices?
Among its 1 most recently registered device, CUSTOM SOFTWARE & ELECTRONICS, S.L has devices listed in EUDAMED (1 device).
What risk classes do CUSTOM SOFTWARE & ELECTRONICS, S.L's devices fall under?
Among its 1 most recently registered device, the classes recorded for CUSTOM SOFTWARE & ELECTRONICS, S.L's devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for CUSTOM SOFTWARE & ELECTRONICS, S.L?
EUDAMED lists 1 certificate for CUSTOM SOFTWARE & ELECTRONICS, S.L (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 17 Apr 2026.
What are the newest devices from CUSTOM SOFTWARE & ELECTRONICS, S.L in the registry?
The most recently registered devices listed for CUSTOM SOFTWARE & ELECTRONICS, S.L include MEDICALCSE.