Abiogen Pharma S.p.A.

Certificate CSQ003426

Rev. 00Issued

Valid until: Mar 19, 2031

Certificate CSQ003426 is a valid Quality management system issued to Abiogen Pharma S.p.A. and registered in EUDAMED. Valid until March 19, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: CSQ003426
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0373CSQ00342600

Validity

Issued: Mar 20, 2026
Valid from: Mar 20, 2026
Valid until: Mar 19, 2031

Manufacturer

Manufacturer: Abiogen Pharma S.p.A.
Manufacturer SRN: IT-MF-000029973
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0373
Notified body country: Italy

Covered devices

ABIO32/18Class III
805651586P90040211001ZL

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

No status changes or preceding certificates are recorded.

Scope coverage

Class III1

1 scope

DEVICE
Class III

Documents

LanguagesENIT