SIFI S.p.A.

Certificate 027-00-05-MDR

Rev. 05Issued

Valid until: Aug 31, 2028

Certificate 027-00-05-MDR is a valid Quality management system issued to SIFI S.p.A. and registered in EUDAMED. Valid until August 31, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 027-00-05-MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0426027-00-05-MDR05

Validity

Issued: Mar 25, 2026
Valid from: Mar 25, 2026
Valid until: Aug 31, 2028

Manufacturer

Manufacturer: SIFI S.p.A.
Manufacturer SRN: IT-MF-000020853
Manufacturer country: Italy

Notified body

Notified body: ITALCERT SRL
Notified body SRN: 0426
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

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: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4

4 scopes

Non-active soft tissue and other implants
Class IIb
Non-active non-implantable ophthalmologic devices
Class IIb
Intraocular lens
Class IIb
Eye lubricant solution
Class IIb

Documents

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