Kaltek S.r.l.

Certificate IT348898

Rev. 1Issued

Valid until: Jan 12, 2030

Certificate IT348898 is a valid Quality management system issued to Kaltek S.r.l. and registered in EUDAMED. Valid until January 12, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: IT348898
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3488981

Validity

Issued: Jan 13, 2026
Valid from: Jan 13, 2026
Valid until: Jan 12, 2030

Notified body

Notified body: BUREAU VERITAS ITALIA S.P.A.
Notified body SRN: 1370
Notified body country: Italy

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: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

M9001 - CRYOTHERAPY AND THERMOTHERAPY DEVICES
Class IIa
DEVICE
Class IIa

Documents

LanguagesIT