Data / Medical devices / Switzerland / Fabrinal SA
Fabrinal SA: FDA-registered device maker in LA CHAUX-DE-FONDS Neuchatel, Switzerland, 1 510(k) clearance
Fabrinal SA is registered with the FDA (registration 3004072823) in LA CHAUX-DE-FONDS Neuchatel, Switzerland. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 31, 1983. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004072823
- Address
- Rue De La Tuilerie 42, LA CHAUX-DE-FONDS Neuchatel, Switzerland, CH-2300
- Owner or operator
- Fabrinal (9089180)
- Roles
- Manufacturer
- First device listed
- June 28, 2006
- Registered through
- 2026
- Brand names listed
- ERG Jet Electrode, Tran Goniowash
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Ophthalmic | HMX | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Corneal | HLZ | 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 |
|---|---|---|---|---|---|---|
| March 31, 1983 | K830557 | ERG-JET ELECTRODE | HLZ | Substantially Equivalent | Universo S.A. | accessdata.fda.gov |
Compare with other makers
Updated March 31, 1983. 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.