Data / Medical devices / Italy / Tecnimed S.R.L.
Tecnimed S.R.L.: FDA-registered device maker in VEDANO OLONA Varese, Italy, 4 510(k) clearances
Tecnimed S.R.L. is registered with the FDA (registration 9615140) in VEDANO OLONA Varese, Italy. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 19, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615140
- FEI number
- 3003334361
- Address
- P. Le Cocchi, 12 Industrial Zone, VEDANO OLONA Varese, Italy, 21040
- Owner or operator
- TECNIMED S.R.L. (9039546)
- Roles
- Manufacturer
- First device listed
- July 25, 2012
- Registered through
- 2026
- Brand names listed
- Click, Disc-o-Click, Infrared Thermometer VisioFocus MINI, Infrared Thermometer VisioFocus SMART, Infrared Thermometers, Series: VisioFocus, Infrared Thermometers, Series: VisioFocus PRO, Mini-Click, Mosquito-Click and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch | OSG | 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 |
|---|---|---|---|---|---|---|
| April 19, 2017 | K160680 | VisioFocus Mini, VisioFocus Smart | FLL | Substantially Equivalent | Tecnimed S.R.L. | accessdata.fda.gov |
| November 7, 2014 | DEN130019 | ZANZA-CLICK | OSG | Unknown | Tecnimed S.R.L. | accessdata.fda.gov |
| March 13, 2013 | K122412 | VISIOFOCUS | FLL | Substantially Equivalent | Tecnimed S.R.L. | accessdata.fda.gov |
| August 31, 2007 | K072108 | MODIFICATION TO THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES | FLL | Substantially Equivalent | Tecnimed S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch
Updated April 19, 2017. 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.