Data / Medical devices / Belgium / S.A. Instrumentation Difra
S.A. Instrumentation Difra: FDA-registered device maker in Eupen Liege, Belgium, 1 510(k) clearance
S.A. Instrumentation Difra is registered with the FDA (registration 9710334) in Eupen Liege, Belgium. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710334
- FEI number
- 3003244948
- Address
- Industriestrasse 33, Eupen Liege, Belgium, 4700
- Owner or operator
- S.A. INSTRUMENTATION DIFRA (9045726)
- Roles
- Manufacturer
- First device listed
- April 24, 2001
- Registered through
- 2026
- Brand names listed
- AirStar, AquaStar, CoolStar, HeadStar V3, Headstar, Headstar Easy, NysStar I, NysStar I Ltd. and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Fixation, Ac-Powered, Ophthalmic | HPL | 1 | Manufacturer | accessdata.fda.gov |
| Drum, Opticokinetic | HOW | 1 | Manufacturer | accessdata.fda.gov |
| Lens, Fresnel, Flexible, Diagnostic | HJJ | 1 | Manufacturer | accessdata.fda.gov |
| Nystagmograph | GWN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Caloric-Air | KHH | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Caloric-Water | ETP | 1 | 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 |
|---|---|---|---|---|---|---|
| September 18, 2007 | K070670 | EYETRACKER/IDEAS | GWN | Substantially Equivalent | S.A. Instrumentation Difra | accessdata.fda.gov |
Compare with other makers
- All makers of Drum, Opticokinetic
- All makers of Nystagmograph
- All makers of Lens, Fresnel, Flexible, Diagnostic
- All makers of Stimulator, Caloric-Water
- All makers of Device, Fixation, Ac-Powered, Ophthalmic
- All makers of Stimulator, Caloric-Air
Updated September 18, 2007. 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.