IBSA FARMACEUTICI ITALIA SRL

Certificate EPT 0477.MDR.23/5076.2

Rev. Rev02Reissued

Valid until: Jun 6, 2027

Certificate EPT 0477.MDR.23/5076.2 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.23/5076.2
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.23/5076.2Rev02

Validity

Issued: Jun 18, 2026
Valid from: Jun 18, 2026
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

HYALURONIC ACID SODIUM SALT FOR INTRADERMAL USEClass III
803363895ID0025G

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.23/5076.1ReissuedAug 8, 2024 → Jun 6, 2027
EPT 0477.MDR.23/5076IssuedFeb 16, 2023 → Jun 6, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III1

1 scope

DEVICE
Class III

Documents

LanguagesENIT