IBSA FARMACEUTICI ITALIA SRL

Certificate EPT 0477.MDR.22/4842.3

Rev. Rev03Reissued

Valid until: Jun 6, 2027

Certificate EPT 0477.MDR.22/4842.3 is a valid Quality management system issued to IBSA FARMACEUTICI ITALIA SRL and registered in EUDAMED. Valid until June 6, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: EPT 0477.MDR.22/4842.3
Certificate type: Quality management system
Certificate status: Reissued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0477EPT 0477.MDR.22/4842.3Rev03

Validity

Issued: Oct 1, 2025
Valid from: Oct 1, 2025
Valid until: Jun 6, 2027

Notified body

Notified body: Eurofins Product Testing Italy S.r.l.
Notified body SRN: 0477
Notified body country: Italy

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
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

Supersedes

EPT 0477.MDR.22/4842.2ReissuedFeb 14, 2025 → Jun 6, 2027
EPT 0477.MDR.22/4842.1ReissuedAug 8, 2024 → Jun 6, 2027
EPT 0477.MDR.22/4842IssuedJun 7, 2022 → Jun 6, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III1

1 scope

DEVICE
Class III