SBM SISTEMI S.R.L.

Certificate 0425-MDR-030104-00

Rev. 00Issued

Valid until: Nov 10, 2029

Certificate 0425-MDR-030104-00 is a valid Quality management system issued to SBM SISTEMI S.R.L. and registered in EUDAMED. Valid until November 10, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030104-00
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04250425-MDR-030104-0000

Validity

Issued: Nov 11, 2024
Valid from: Nov 11, 2024
Valid until: Nov 10, 2029

Manufacturer

Manufacturer: SBM SISTEMI S.R.L.
Manufacturer SRN: IT-MF-000026683
Manufacturer country: Italy

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Topografo corneale
Class IIa
Topografo corneale OS1000
Class IIa

Documents

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