Eye Pharma S.p.a.

Certificate 0425-MDR-030167-00

Rev. 00Issued

Valid until: Dec 21, 2030

Certificate 0425-MDR-030167-00 is a valid Quality management system issued to Eye Pharma S.p.a. and registered in EUDAMED. Valid until December 21, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030167-00
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04250425-MDR-030167-0000

Validity

Issued: Dec 22, 2025
Valid from: Dec 22, 2025
Valid until: Dec 21, 2030

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
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: 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 IIb3Class IIa2

4 scopes

Lenti a contatto Regenera / Soluzione oftalmica Drain Drops / Soluzione oftalmica Eviva Drops Regenera contact lenses / Drain Drops ophthalmic solution / Eviva Drops ophthalmic solution
Class IIbClass IIa
DEVICE
Class IIb
DEVICE
Class IIa
DEVICE
Class IIb