AFERETICA S.R.L.

Certificate ITH 1343916 1

Rev. 3.0Reissued

Valid until: Oct 17, 2029

Certificate ITH 1343916 1 is a valid Quality management system issued to AFERETICA S.R.L. and registered in EUDAMED. Valid until October 17, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: ITH 1343916 1
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1936ITH 1343916 13.0

Validity

Issued: Apr 29, 2026
Valid from: Apr 29, 2026
Valid until: Oct 17, 2029

Manufacturer

Manufacturer: AFERETICA S.R.L.
Manufacturer SRN: IT-MF-000029731
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: Yes
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: No
Intended medical purpose: No
SPP applicable

History

Supersedes

ITH 1343916 1Quality management systemSupplementedJul 14, 2025 → Oct 17, 2029

Scope coverage

Class IIa2Class I1

3 scopes

A0980 CONTENITORI PER ORGANI – ACCESSORI / ORGAN CONTAINERS – ACCESSORIES
Class I
A090199 CONTENITORI PER IL PRELIEVO DI ORGANI – ALTRI / ORGAN COLLECTION CONTAINERS - OTHER
Class IIa
C0399 DISPOSITIVI PER CARDIOCHIRURGIA E TRAPIANTO DI ORGANO – ALTRI / CARDIOSURGERY AND ORGAN TRANSPLANTATION DEVICES – OTHER
Class IIa

Documents

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