CARDIO CALM S.R.L.

Certificate ITH 1343804 1

Rev. 2.0Supplemented

Valid until: Apr 21, 2027

Certificate ITH 1343804 1 is a valid Quality management system issued to CARDIO CALM S.R.L. and registered in EUDAMED. Valid until April 21, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: ITH 1343804 1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1936ITH 1343804 12.0

Validity

Issued: Jul 8, 2024
Valid from: Jul 8, 2024
Valid until: Apr 21, 2027

Notified body

Notified body: TUV Rheinland Italia SRL
Notified body SRN: 1936
Notified body country: Italy

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

Supplemented
Supplemented

Supersedes

ITH 1343804 1Quality management systemIssuedApr 22, 2022 → Apr 21, 2027

Scope coverage

Class IIa4

4 scopes

SOFTWARE
Class IIa
CER-S v. 4.y.z
Class IIa
BPCor v. 1.y.z
Class IIa
ECGCor v. 1.y.z
Class IIa

Documents

LanguagesENIT