KARDI AI Technologies s.r.o.

Certificate 24 0263 QR/NB

Reinstated

Valid until: Jul 28, 2029

Certificate 24 0263 QR/NB is a valid Quality management system issued to KARDI AI Technologies s.r.o. and registered in EUDAMED. Valid until July 28, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 24 0263 QR/NB
Certificate type: Quality management system
Certificate status: Reinstated
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 102324 0263 QR/NB

Validity

Issued: Jul 29, 2024
Valid from: Jul 29, 2024
Valid until: Jul 28, 2029

Manufacturer

Manufacturer: KARDI AI Technologies s.r.o.
Manufacturer SRN: CZ-MF-000026438
Manufacturer country: Czechia

Notified body

Notified body: INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390
Notified body SRN: 1023
Notified body country: Czechia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

Status changes

Reinstated

Supersedes

24 0263 QR/NBQuality management systemSuspendedJul 29, 2024 → Jul 28, 2029

Scope coverage

Class IIa2

2 scopes

Kardi Ai
Class IIa
ECG telemetric monitoring system
Class IIa

Documents

LanguagesCSEN