The Carci Reagent® test is a registered in-vitro diagnostic (IVD) for self-use. It meets the requirements of the EU regulations for medical devices and is certified in accordance with the applicable legislation. On this page you will find an overview of the certifications, approvals and documents that confirm the safety, quality and reliability of the test when used at home.
- Certificate (.pdf)
- EC Declaration of Conformity (.pdf)
- EC Declaration of Conformity (new) (.pdf)
- Confirmation Letter (.pdf)
- ISO 13485
- Certificate of Achievement - Mag. Martin Muzikant, Ph.D.
- Certificate of Attendance - Mag. Martin Muzikant, Ph.D.
- APA Code PharmData
- Free Sale Certificate, SÚKL
- Notification of the IVD product CarciReagent to SÚKL
- Registration of CNEU MEDICAL s.r.o. with SÚKL