Sixtem Life Srl

Certificate 55191

Rev. 0Issued

Valid until: Dec 22, 2027

Certificate 55191 is a valid Quality management system issued to Sixtem Life Srl and registered in EUDAMED. Valid until December 22, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 55191
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0546551910

Validity

Issued: Dec 23, 2022
Valid from: Dec 23, 2022
Valid until: Dec 22, 2027

Notified body

Notified body: CERTIQUALITY S.r.l.
Notified body SRN: 0546
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: Yes
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

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Active non-implantable devices utilising hyperthermia/hypothermia
Class IIa
Medical device for the cryotherapy treatment of warts on the hands and feet
Class IIa