Data / Medical devices / Switzerland / Polichem SA
Polichem SA: FDA-registered device maker in Mendrisio Ticino, Switzerland, 1 510(k) clearance
Polichem SA is registered with the FDA (registration 3005427465) in Mendrisio Ticino, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2009. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005427465
- Address
- Via Angelo Maspoli 11 Polichem SA, Via Angelo Maspoli 11, 6850 Mendrisio, Switzerland, Mendrisio Ticino, Switzerland, 6850
- Owner or operator
- Polichem SA (10036234)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- April 25, 2011
- Registered through
- 2027
- Brand names listed
- Genadur
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid | KMF | 1 | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 7, 2009 | K083087 | ECOCEL | KMF | Substantially Equivalent | Polichem S.A | accessdata.fda.gov |
Compare with other makers
Updated August 7, 2009. 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.