Data / Medical devices / Italy / Bioplax Italia SRL
Bioplax Italia SRL: FDA-registered device maker in Milan Lombardy, Italy, 1 510(k) clearance
Bioplax Italia SRL is registered with the FDA (registration 3029906643) in Milan Lombardy, Italy. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 4, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029906643
- Address
- Via G Leopardi 21, Milan Lombardy, Italy, 20123
- Owner or operator
- Bioplax Italia (10088763)
- Roles
- Manufacturer
- First device listed
- October 23, 2023
- Registered through
- 2026
- Brand names listed
- Aftamed Forte Gel, Aftamed Gel, Aftamed Junior Gel, Aftamed Mouthwash, Aftamed Spray
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oral Wound Dressing | OLR | U | 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 4, 2014 | K130959 | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL | OLR | Substantially Equivalent | Bioplax Limited | accessdata.fda.gov |
Compare with other makers
Updated April 4, 2014. 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.