A.T.S. Applicazione Tecnologie Speciali s.r.l.

Certificate ITH 2492603 1

Rev. 2.0Supplemented

Valid until: Dec 10, 2028

Certificate ITH 2492603 1 is a valid Quality management system issued to A.T.S. Applicazione Tecnologie Speciali s.r.l. and registered in EUDAMED. Valid until December 10, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: ITH 2492603 1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1936ITH 2492603 12.0

Validity

Issued: May 16, 2025
Valid from: May 16, 2025
Valid until: Dec 10, 2028

Manufacturer

Manufacturer: A.T.S. Applicazione Tecnologie Speciali s.r.l.
Manufacturer SRN: IT-MF-000010734
Manufacturer country: Italy

Notified body

Notified body
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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

ITH 2492603 1Quality management systemIssuedMay 8, 2024 → Dec 10, 2028

Scope coverage

Class IIb2

2 scopes

Dispositivi non impiantabili attivi per immagini che utilizzano radiazioni ionizzanti / Active non-implantable imaging devices utilising ionizing radiation
Class IIb
Software
Class IIb

Documents

LanguagesENIT