IBSA FARMACEUTICI ITALIA SRL

Certificate EPT 0477.MDR.22/4994.2

Rev. Rev02Reissued

Valid until: Jun 6, 2027

Certificate EPT 0477.MDR.22/4994.2 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.22/4994.2
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.22/4994.2Rev02

Validity

Issued: Dec 19, 2025
Valid from: Dec 19, 2025
Valid until: Jun 6, 2027

Manufacturer

Manufacturer: IBSA FARMACEUTICI ITALIA SRL
Manufacturer SRN: IT-MF-000008111
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0477
Notified body country: Italy

Covered devices

HILOW HYALURONIC ACID SODIUM SALT FOR VAGINAL USEClass III
803363895ID0015E

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

History

Supersedes

EPT 0477.MDR.22/4994.1ReissuedJul 1, 2024 → Jun 6, 2027
EPT 0477.MDR.22/4994IssuedNov 23, 2022 → Jun 6, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III1

1 scope

DEVICE
Class III

Documents

LanguagesENIT