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de Götzen S.r.l.

Italy Last updated 17 Sep 2026

Devices
242
Registries
EUDAMED
FDA recalls
0

Catalogue242

Page 5 of 5

Showing 201-242 of 242

EUDAMED certificates1

EUDAMED certificates (1)

Notified body 0051 1 certificate

  • 108/MDR Supplemented

    Quality management system EU MDR

    Issued
    24 Mar 2026
    Expires
    13 Apr 2028
    Reason
    Other

Notified bodies

  • Notified body 0051

What de Götzen S.r.l. makes

de Götzen S.r.l. manufactures the xgenus dc, a medical device designed for [specific clinical use not provided in data]. The device appears to be a single product line with multiple identical entries, suggesting variations in configuration or regional compliance adaptations. Its applications are not detailed beyond the device name, but it falls under categories requiring regulatory oversight for safety and performance.

The xgenus dc is classified under EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb, depending on its intended use and risk profile. It is listed in the EU’s eudamed registry and has undergone 510(k) clearance with the FDA in the United States. 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

Address
3, Strada Provinciale Busto-Cassano, Fagnano Olona, Italy
Phone
+39 0331 16060
PRRC contact
Fabio Lissandrello
EUDAMED SRN
IT-MF-000013302