Regulatory information
Legal information · About VR-CARDIO
VR-CARDIO is medical device software, CE marked under Regulation (EU) 2017/745. This page identifies it as the regulation requires.
VR-CARDIO
Software version: 1.0.0
Device identification (UDI)
Basic UDI-DI: 8437028381VR-CARDIOL4
UDI-DI: 08437028381002
UDI-PI: 1.0.0
Manufactured by: SPIKA TECH, S.L. | C/ Alcalá de Guadaira, 6, 6º A derecha, 28018 Madrid, España
Regulatory identification
- Legal manufacturer
- SPIKA TECH, S.L.
C/ Alcalá de Guadaira, 6, 6º A derecha, 28018 Madrid, España - Manufacturer SRN
ES-MF-000044822- CE marking
- Notified body
- HTCert (identification number 2803)
- Certificate
C08 ES044822 2512 Rev.00- Conformity assessment
- Annex IX, Chapters I and III
- Risk class
- Class IIb (Annex VIII, Regulation (EU) 2017/745)
- Basic UDI-DI
8437028381VR-CARDIOL4- UDI-DI (device identifier)
08437028381002- UDI-PI (production identifier: software version)
1.0.0- Full UDI (human-readable)
(01)08437028381002(8012)1.0.0- REF
8437028381VR-CARDIOL4- Date of manufacture
- 2024-12-02
- EU declaration of conformity
- Issued in Madrid on 22 October 2026 under the sole responsibility of SPIKA TECH, S.L.
Intended purpose
Medical software for the non-invasive electroanatomical reconstruction and three-dimensional visualisation of the heart's electrical activity.
For use only by authorised medical professionals. Read the instructions for use before using the product.
Instructions for use (eIFU)
Contact and incident reporting
To report an incident or ask about the product, write to admin.its@spikatech.com.