Data / Medical devices / Germany / Rodenstock GmbH
Rodenstock GmbH: FDA-registered device maker in Munich Bavaria, Germany, 2 510(k) clearances
Rodenstock GmbH is registered with the FDA (registration 3010069263) in Munich Bavaria, Germany. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010069263
- Address
- Elsenheimer Strasse 33, Munich Bavaria, Germany, 80687
- Owner or operator
- Rodenstock Gmbh (9055622)
- Roles
- Exporter to the US, Foreign private label distributor, Specification developer
- First device listed
- March 27, 2003
- Registered through
- 2026
- Brand names listed
- DNEye Scanner 2+, DNEye Scanner 2 , VX120, VX118, DNEye Scanner 3, Rodenstock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Specification developer | accessdata.fda.gov |
| Frame, Spectacle | HQZ | 1 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Lens, Spectacle, Non-Custom (Prescription) | HQG | 1 | Specification developer | accessdata.fda.gov |
| Spectacle, Magnifying | HOI | 1 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Tonometer, Ac-Powered | HKX | 2 | 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 |
|---|---|---|---|---|---|---|
| January 29, 2021 | K202221 | VX650 | HKI | Substantially Equivalent | Luneau Technology Operations | accessdata.fda.gov |
| June 1, 2015 | K143086 | VX120 Ophthalmic Diagnostic Device | HKX | Substantially Equivalent | Luneau Sas | accessdata.fda.gov |
Compare with other makers
- All makers of Tonometer, Ac-Powered
- All makers of Spectacle, Magnifying
- All makers of Sunglasses (Non-Prescription Including Photosensitive)
- All makers of Camera, Ophthalmic, Ac-Powered
- All makers of Frame, Spectacle
- All makers of Lens, Spectacle, Non-Custom (Prescription)
Updated January 29, 2021. 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.