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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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Diaco Biofarmaceutici srl

Certificate CSQ0033260126

Rev. 01Supplemented
Valid until
Feb 11, 2031

Overview

Certificate number
CSQ0033260126
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
0373CSQ003326012601

Validity

Issued
Feb 12, 2026
Valid from
Feb 12, 2026
Valid until
Feb 11, 2031

Manufacturer

Manufacturer
Diaco Biofarmaceutici srl
Manufacturer SRN
IT-MF-000012117
Manufacturer country
Italy

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
No
New device
No
Discard allowed
No
SSCP enabled
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
No
QMS/MOS type
Basic UDI-DI data only

History

Status changes

  • Supplemented

Supersedes

  • CSQ003326Quality management systemIssuedFeb 12, 2026 → Feb 11, 2031

Scope coverage

Class III2

2 scopes

  • DEVICE
    Class III
  • DEVICE
    Class III

Documents

LanguagesENIT

Covered devices

  • Diart OneClass III
    805902020FILLERHCL3G
  • DiartClass III
    805902020FILLERHC4