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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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Tesi Elettronica e Sistemi Informativi S.p.A.

Certificate IT339901

Rev. 1Issued
Valid until
Feb 6, 2030

Overview

Certificate number
IT339901
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1370IT3399011

Validity

Issued
Feb 7, 2025
Valid from
Feb 7, 2025
Valid until
Feb 6, 2030

Manufacturer

Manufacturer
Tesi Elettronica e Sistemi Informativi S.p.A.
Manufacturer SRN
IT-MF-000021278
Manufacturer country
Italy

Notified body

Notified body
BUREAU VERITAS ITALIA S.P.A.
Notified body SRN
1370
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
Yes
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

  • Strumentazione per emotrasfusione - Altra - MDA 0315 - Software
    Class IIb
  • EMOWEB (Versione 4)
    Class IIb

Documents

LanguagesIT