Alfa Intes Industria Terapeutica Splendore S.r.l.

Certificate CSQ0023240225

Rev. 02Supplemented

Valid until: Jun 13, 2029

Certificate CSQ0023240225 is a valid Quality management system issued to Alfa Intes Industria Terapeutica Splendore S.r.l. and registered in EUDAMED. Valid until June 13, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: CSQ0023240225
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0373CSQ002324022502

Validity

Issued: May 26, 2025
Valid from: May 26, 2025
Valid until: Jun 13, 2029

Notified body

Notified body: ISTITUTO SUPERIORE DI SANITA'
Notified body SRN: 0373
Notified body country: Italy

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: No
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

Status changes

Supplemented

Supersedes

CSQ0023240124Quality management systemSupplementedJun 14, 2024 → Jun 13, 2029

Scope coverage

Class III1

1 scope

DEVICE
Class III