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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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ASSUT EUROPE SPA

Certificate CSQ0013230724

Rev. 07Supplemented
Valid until
Aug 7, 2028

Certificate CSQ0013230724 is a valid Quality management system issued to ASSUT EUROPE SPA and registered in EUDAMED. Valid until August 7, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
CSQ0013230724
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
7
Certificate ID
0373CSQ001323072407

Validity

Issued
Oct 8, 2024
Valid from
Oct 8, 2024
Valid until
Aug 7, 2028

Notified body

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

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
Yes
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

  • CSQ0013230624Quality management systemSupplementedOct 8, 2024 → Aug 7, 2028

Scope coverage

Class III6

6 scopes

  • FilBloc - Synthetic long term absorption, smooth or barbed, self- retaining surgical suture poly(p-dioxanone) monofilament, sterile SYMMCORA long - Synthetic long term absorption, smooth or barbed, self-retaining surgical suture PDO monofilament, sterile
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III
  • DEVICE
    Class III

Manufacturer

Manufacturer
ASSUT EUROPE SPA
Manufacturer SRN
IT-MF-000018178
Manufacturer country
Italy

Covered devices

  • FILBLOCClass III
    8033439FILBLOCPDOV7
  • Bioripar - Bovine Pericardium MembraneClass III
    8033439BIORIPARBOVINOVN
  • FILBLOC PERMANENTClass III
    8033439FILBLOCPERMHW
  • ASSUFIL MONOFILAMENTOClass III
    8033439ASSUFILM-PDOUG
  • FILBLOC 90Class III
    8033439FILBLOC908G

Documents

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