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NOVYSTEM S.p.A.

Italy IT-MF-000032699 Last updated 17 Sep 2026

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Devices
1
Registries
EUDAMED
FDA recalls
0

Catalogue1

  • Sep4Angio Ref NS-STEM-33

    Class IIa EUDAMED Active

EUDAMED certificates1

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

EUDAMED certificates (1)

ICIM S.P.A. 0425 1 certificate

  • 0425-MDR-030023-00 Withdrawn

    Quality assurance EU MDR

    Issued
    28 Apr 2023
    Expires
    27 Apr 2028
    Reason
    Not on market

Notified bodies

About

Scientists at University of Milan in collaboration with Novystem published in Science Translation Medicine magazine that gold quantum clusters

From the manufacturer's own website. Source

What NOVYSTEM S.p.A. makes

Novystem S.p.A. makes the Sep4Angio device.

The Sep4Angio device is classified as Class IIa and is listed in the Eudamed registry; the company is based in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
Italy
Address
21, Viale Piave, Milano (MI), Italy
Phone
+39 02 87169128
PRRC contact
Silvia Erratico
EUDAMED SRN
IT-MF-000032699