Data / Medical devices / Italy / M.R.S. SRL
M.R.S. SRL: FDA-registered device maker in Gazzaniga Bergamo, Italy, 1 510(k) clearance
M.R.S. SRL is registered with the FDA (registration 3010608097) in Gazzaniga Bergamo, Italy. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 21, 2003. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010608097
- Address
- Via C. Battisti, 134, Gazzaniga Bergamo, Italy, 24025
- Owner or operator
- M.R.S. Srl (10045540)
- Roles
- Manufacturer
- First device listed
- November 27, 2013
- Registered through
- 2026
- Brand names listed
- R07A, R140, R15C, R15C-T, R16M, R17A, R25C, R25CPT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Tester, Auditory Impedance | ETY | 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 |
|---|---|---|---|---|---|---|
| July 21, 2003 | K031978 | AMPLAID A756 SCREENING ADMITTANCE METER | ETY | Substantially Equivalent | Amplaid | accessdata.fda.gov |
Compare with other makers
- All makers of Tester, Auditory Impedance
- All makers of Medical Device Data System
- All makers of Audiometer
- All makers of Otoscope
Updated July 21, 2003. 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.