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de Götzen S.r.l.

Italy Last updated 17 Sep 2026

Devices
242
Registries
EUDAMED
FDA recalls
0

Catalogue242

Page 2 of 5

  • Leadex70 dc Ref 5.92.23330

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.23331

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.22335

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.23332

    Class IIb EUDAMED Active

  • Sds Kerr 4000 Ref 6.01.00132

    Class I EUDAMED Active

  • x-mind dc Ref 5.92.23153

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.15078

    Class IIb EUDAMED Active

  • x-mind dc Ref 5.92.15130

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.22332

    Class IIb EUDAMED Active

  • Leadex70 dc Ref 5.92.23332

    Class IIb EUDAMED Active

  • Softly Ref 6.01.00114

    Class I EUDAMED Active

  • x-mind dc Ref 5.92.15107

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.22033

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.23039

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.23036

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.22333

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.22035

    Class IIb EUDAMED Active

  • xgenus Ref 5.91.23032

    Class IIb EUDAMED Active

  • Leadex70 dc Ref 5.92.23335

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.15071

    Class IIb EUDAMED Active

  • x-mind dc Ref 5.92.15100

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.15988

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.15073

    Class IIb EUDAMED Active

  • x-mind dc Ref 5.92.15102

    Class IIb EUDAMED Active

  • x-mind dc Ref 5.92.15101

    Class IIb EUDAMED Active

  • Softly 8 Ref 6.01.00121

    Class I EUDAMED Active

  • X-MIND prime Ref W1200001

    Class IIb EUDAMED Active

  • Leadex70 dc Ref 5.92.23367

    Class IIb EUDAMED Active

  • xgenus Ref 5.91.23031

    Class IIb EUDAMED Active

  • Leadex70 dc Ref 5.92.23366

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.22030

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.23367

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.15075

    Class IIb EUDAMED Active

  • x-mind dc Ref 5.92.15985

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.23035

    Class IIb EUDAMED Active

  • Leadex70 dc Ref 5.92.23361

    Class IIb EUDAMED Active

  • Leadex70 Ref 5.90.23365

    Class IIb EUDAMED Active

  • xgenus Ref 5.90.22032

    Class IIb EUDAMED Active

  • x-mind dc Ref 5.92.23137

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23036

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23030

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23995

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.93.23031

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23038

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23032

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23037

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23051

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.93.23035

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.92.23989

    Class IIb EUDAMED Active

  • xgenus dc Ref 5.93.23032

    Class IIb EUDAMED Active

Showing 51-100 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

Related companies

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