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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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Bruschettini s.r.l.

Certificate CSQ002424

Rev. 00Issued
Valid until
Feb 7, 2029

Certificate CSQ002424 is a valid Quality management system issued to Bruschettini s.r.l. and registered in EUDAMED. Valid until February 7, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
CSQ002424
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0373CSQ00242400

Validity

Issued
Jul 1, 2024
Valid from
Jul 1, 2024
Valid until
Feb 7, 2029

Notified body

Notified body
ISTITUTO SUPERIORE DI SANITA'
Notified body SRN
0373
Notified body country
Italy

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
Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb10

10 scopes

  • Clarastill Clarastill Sine
    Class IIb
  • KERATOSEPT KERATOSEPT PRO
    Class IIb
  • KERATOSTILL KERATOSTILL SINE OmniMed protect PAN-VISION KERATODROP EyeStill DualCare KORNEOL
    Class IIb
  • Gel 4000
    Class IIb
  • OmniMed comfort LACRI-VISION
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb

Documents

LanguagesENIT

Manufacturer

Manufacturer
Bruschettini s.r.l.
Manufacturer SRN
IT-MF-000027211
Manufacturer country
Italy

Covered devices

  • CLARASTILLClass IIb
    805051347BRU00127
  • KERATOSEPTClass IIb
    805051347BRU0052F
  • KERATOSTILLClass IIb
    805051347BRU00229
  • GEL 4000Class IIb
    805051347BRU0032B
  • LACRI-VISIONClass IIb
    805051347BRU0042D