AFEA S.R.L.

Certificate IT350316

Rev. 1Issued

Valid until: Feb 23, 2031

Certificate IT350316 is a valid Quality management system issued to AFEA S.R.L. and registered in EUDAMED. Valid until February 23, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: IT350316
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1370IT3503161

Validity

Issued: Feb 24, 2026
Valid from: Feb 24, 2026
Valid until: Feb 23, 2031

Manufacturer

Manufacturer: AFEA S.R.L.
Manufacturer SRN: IT-MF-000044680
Manufacturer country: Italy

Notified body

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

Covered devices

H2O CCEClass IIb
805780817-H2O+CCE-AZ

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

DISPOSITIVI MEDICI SOFTWARE - NON COMPRESI IN ALTRE CLASSI
Class IIb
DEVICE
Class IIb

Documents

LanguagesIT