General Medical Merate S.p.A.
IT-MF-000023169 · Italy · Seriate
General Medical Merate S.p.A. is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 77 |
|---|---|
| Class IIb | 1 |
Most frequent device types declared: Ceiling, RF rooms, Table for RAD rooms, Wall Stand units.
Devices declared under this manufacturer
- MBA_200
- MBAe
- MBAf
- MBAfp
- MCP-SL
- MSP-ST
- MSP150
- MTOE-D
- O-RS20
- TRN43-D
- TRN430
- TRN43X/MT
Showing 12 of 78 declared devices.
Catalogue references include MBAe, MBAf, MCP-SL, MTOE-D, O-RS20, TRN43-D.
European nomenclature codes declared: Z11030502, V0899, Z11030506, Z11030503, Z11030501, Z11039009.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | GENERAL MEDICAL MERATE S.P.A. (IT) · FDA 8020997 |
| Devices in EUDAMED | 78 |
| Country of registration | Italy |
Device-level evidence
| Devices with a numeric GTIN | 78 |
|---|---|
| Found in the U.S. device database | 5 |
| Share | 6.4 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | GENERAL MEDICAL MERATE S.P.A. |
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 4 |
| First licensed | 2005-05-27 |
Licence types: System (4).
Licensed under: OPERA, OPERA FP, OPERA SWING - R/F REMOTE CONTROL SYSTEM, DISCOVERY RF180.
North American profile: Both markets. General Medical Merate S.p.A. is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
050/MDR | supplemented | 2027-09-29 |