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GENERAL MEDICAL MERATE S.P.A.

Italy IT-MF-000023169 Last updated 23 Oct 2026

Devices
70
Registries
EUDAMEDGUDIDFDA 510(k)FDA
FDA recalls
0

Catalogue70

Page 1 of 2

Showing 1-50 of 70

EUDAMED certificates1

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

EUDAMED certificates (1)

Notified body 0051 1 certificate

  • 050/MDR Supplemented

    Quality management system EU MDR

    Issued
    7 Oct 2026
    Expires
    29 Sep 2027
    Reason
    Change approved

Notified bodies

  • Notified body 0051

What GENERAL MEDICAL MERATE S.P.A. makes

General Medical Merate S.p.A. manufactures X-ray generating systems, including analog and digital mobile C-arm units (e.g., MTH C/A MOBILE C ARM) and fixed systems (e.g., PRECISION RXI). Their portfolio also includes clisis systems (e.g., Discovery RF180) for intravenous fluid administration and swing-frame systems (e.g., OPERA SWING) for patient positioning in medical imaging. Additional offerings include specialized X-ray equipment like the TF 1000 X-ray generating system and GE Medical Systems SCS components.

The company’s devices are classified under EU regulations as Class I or Class II, with relevant entries listed in the EUDAMED database. Some products are also documented in the FDA’s 510(k) registry under U.S. clearance requirements. The manufacturer 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
25, Via Partigiani , Seriate, Italy
Phone
+39 035 45 25 311
PRRC contact
Alessandro Mozzi
EUDAMED SRN
IT-MF-000023169
FDA FEI number
3002807092