Data / Medical devices / Calibrator, Secondary / France
FDA-registered makers of Calibrator, Secondary in France: 5 establishments
5 establishments in France are registered with the FDA to make Calibrator, Secondary (product code JIT). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Calibrator, Secondary
- Product code
- JIT
- Country
- France
Makers of Calibrator, Secondary in France
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Horiba Abx SAS | MONTPELLIER Herault, France | Manufacturer, Specification developer | 2 | October 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| Immunotech SAS, a Beckman Coulter company | MARSEILLE, CEDEX 9 Bouches-du-Rhone, France | Contract manufacturer, Manufacturer, Specification developer | 1 | October 5, 2004 | 0 | 0 | 0 | api.fda.gov |
| VitalScientific | SEES Normandie, France | Manufacturer | 1 | February 15, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cezanne SAS | NIMES Gard, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hyphen Biomed Sasu | NEUVILLE SUR OISE Val-d'Oise, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.