Data / Medical devices / Italy / General Medical Merate S.P.A.
General Medical Merate S.P.A.: FDA-registered device maker in Seriate, Bergamo, Italy, 3 510(k) clearances
General Medical Merate S.P.A. is registered with the FDA (registration 8020997) in Seriate, Bergamo, Italy. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 26, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020997
- FEI number
- 3002807092
- Address
- Via Partigiani, 25, Seriate, Bergamo, Italy, 24068
- Owner or operator
- GENERAL MEDICAL MERATE S.P.A. (8020997)
- Roles
- Manufacturer
- First device listed
- October 23, 2014
- Registered through
- 2026
- Brand names listed
- CLISIS SYSTEMS, CLISIS SYSTEMS, Discovery RF180, Discovery RF180, Opera Swing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomographic | IZF | 2 | Manufacturer | accessdata.fda.gov |
| Table, Radiologic | KXJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2021 | K213081 | CLISIS SYSTEMS, Discovery RF180 | IZF | Substantially Equivalent | General Medical Merate S.P.A | accessdata.fda.gov |
| May 21, 2018 | K173395 | MECALL CLISIS SYSTEMS, Discovery RF180 | JAA | Substantially Equivalent | General Medical Merate S.P.A | accessdata.fda.gov |
| September 26, 2014 | K140380 | OPERA SWING | JAA | Substantially Equivalent | General Medical Merate S.P.A | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomographic
- All makers of System, X-Ray, Angiographic
- All makers of Table, Radiologic
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated October 26, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.