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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Oculox Technologies SA

Certificate IT349481

Rev. 1Issued
Valid until
Jan 29, 2030

Certificate IT349481 is a valid Quality management system issued to Oculox Technologies SA and registered in EUDAMED. Valid until January 29, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
IT349481
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1370IT3494811

Validity

Issued
Jan 30, 2026
Valid from
Jan 30, 2026
Valid until
Jan 29, 2030

Notified body

Notified body
BUREAU VERITAS ITALIA S.P.A.
Notified body SRN
1370
Notified body country
Italy

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
Yes
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

  • Z12120202 - Laser Photocoagulator
    Class IIb
  • DEVICE
    Class IIb

Manufacturer

Manufacturer
Oculox Technologies SA
Manufacturer SRN
CH-MF-000038775
Manufacturer country
Switzerland

Covered devices

  • retinaSEESClass IIb
    76499881684RetinaSeesPN

Documents

LanguagesITEN