GENERAL MEDICAL MERATE S.P.A.
Italy Last updated 25 Oct 2026
- Devices
- 73
- Registries
- EUDAMEDGUDIDFDA
- FDA recalls
- 0
Catalogue
TRT43-D Ref TRT43-D
Mcp-Sl Ref MCP-SL
TRN43-B Ref TRN43-B
CT160F Ref CT160F
TRT43-B Ref TRT43-B
O-RS10 Ref O-RS10
TT9222 Ref TT9222
CL31AT Ref CL31AT
Polistat M Ref POLISTAT M
BT7630 Ref BT7630
TRN43-D Ref TRN43-D
TT9212 Ref TT9212
TRT43-S Ref TRT43-S
TRN430 Ref TRN430/GMA
45640 Ref 45640
TT9241 Ref TT9241
Msp-Ma Ref MSP-MA
CS31SL Ref CS31SL
Mcp-Ma Ref MCP-MA
TRN43X/Mt Ref TRN43X/MT
Ws-Sx Ref WS-SX
Mtoe-B Ref MTOE-B
Wst-Sx Ref WST-SX
Showing 51-73 of 73
EUDAMED certificates
Notified body 0051 1 certificate
- 050/MDR Supplemented
Quality management system EU MDR
- Issued
- 7 Oct 2026
- Expires
- 29 Sep 2027
- Reason
- Change approved
Related companies
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.
Information
- Address
- 25, Via Partigiani , Seriate, Italy
- Website
- www.gmmspa.com/
- [email protected]
- Phone
- +39 035 45 25 311
- PRRC contact
- Alessandro Mozzi
- EUDAMED SRN
- IT-MF-000023169
- FDA FEI number
- 3002807092