Data / Medical devices / Italy / Bionen SRL
Bionen SRL: FDA-registered device maker in Florence Firenze, Italy, 1 510(k) clearance
Bionen SRL is registered with the FDA (registration 3008617703) in Florence Firenze, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 7, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008617703
- Address
- Via P. Petrocchi, 42/1, Florence Firenze, Italy, 50127
- Owner or operator
- Bionen SRL (10034049)
- Roles
- Manufacturer
- First device listed
- November 2, 2010
- Registered through
- 2026
- Brand names listed
- Disposable Concentric Needle Electrode, Disposable Monopolar Needle Electrode, Disposable Monopolar/Subdermal Needle Electrode, FasTip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle | GXZ | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Needle, Diagnostic Electromyograph | IKT | 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 7, 2010 | K092973 | DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE | IKT | Substantially Equivalent | Bionen S.A.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrocardiograph
- All makers of Electrode, Needle, Diagnostic Electromyograph
- All makers of Electrode, Needle
Updated October 7, 2010. 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.