Aeffe Farmaceutici S.r.l.

Certificate IT347304

Rev. 1Issued

Valid until: Nov 16, 2030

Certificate IT347304 is a valid Quality management system issued to Aeffe Farmaceutici S.r.l. and registered in EUDAMED. Valid until November 16, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: IT347304
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3473041

Validity

Issued: Nov 17, 2025
Valid from: Nov 17, 2025
Valid until: Nov 16, 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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

G99 - GASTROINTESTINAL DEVICES - OTHER
Class IIb
DEVICE
Class IIb