Data / Medical devices / France / Medicos Rombach
Medicos Rombach: FDA-registered device maker in ROMBACH LE FRANC Haut-Rhin, France, 2 510(k) clearances
Medicos Rombach is registered with the FDA (registration 3010612624) in ROMBACH LE FRANC Haut-Rhin, France. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 6, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010612624
- Address
- 96 rue du General de Gaulle, ROMBACH LE FRANC Haut-Rhin, France, 68660
- Owner or operator
- MEDICOS ROMBACH (10045444)
- Roles
- Manufacturer
- First device listed
- November 18, 2013
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Case, Contact Lens | LRX | 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 |
|---|---|---|---|---|---|---|
| August 6, 2013 | K131875 | MENICON NECT CONTACT LENS CASE | LRX | Substantially Equivalent | Foresight Regulatory Strategies | accessdata.fda.gov |
| April 7, 1995 | K950878 | MENICON SP VIAL | LRX | Substantially Equivalent | Hyman, Phelps & McNamara, P.C. | accessdata.fda.gov |
Compare with other makers
Updated August 6, 2013. 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.