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Quanta System S.p.A.

Italy IT-MF-000007393 Last updated 8 Jun 2026

Devices
246
Registries
EUDAMEDGUDID
FDA recalls
6

Catalogue246

Page 1 of 5

Showing 1-50 of 246

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

TÜV SÜD Product Service GmbH 0123 2 certificates

  • G15 095419 0015 Reissued

    Quality management system EU MDR

    Issued
    15 Sep 2026
    Expires
    13 Dec 2031
    Valid from
    14 Dec 2026
  • G10 095419 0012 Issued Expires in 49 days

    Quality management system EU MDR

    Issued
    6 Oct 2023
    Expires
    13 Dec 2026

Notified bodies

FDA recalls6

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2021

    • 27 Apr 2021 Z-1842-2021 Class II Terminated Product sterility is potentially compromised.
    • 27 Apr 2021 Z-1843-2021 Class II Terminated Product sterility is potentially compromised.
    • 27 Apr 2021 Z-1844-2021 Class II Terminated Product sterility is potentially compromised.
  • 2012

    • 7 Nov 2012 Z-0691-2013 Class II Terminated Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
    • 7 Nov 2012 Z-0692-2013 Class II Terminated Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.
    • 7 Nov 2012 Z-0693-2013 Class II Terminated Quanta System S.p.A, Italy, is notifying U.S. consignees that their website contained promotional materials for products distributed in the U.S. which did not specify that some of the claims made therein were not meant to apply to the U.S. distributed devices.

Information

Country
Italy
Address
109, via Acquedotto, Samarate, Italy
Phone
+390331376797
PRRC contact
Dario Bandiera
EUDAMED SRN
IT-MF-000007393