Data / Medical devices / Germany / EIZO GmbH
EIZO GmbH: FDA-registered device maker in Ruelzheim Rhineland-Palatinate, Germany, 1 510(k) clearance
EIZO GmbH is registered with the FDA (registration 3006615345) in Ruelzheim Rhineland-Palatinate, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 22, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006615345
- Address
- Carl-Benz-Strasse 3, Ruelzheim Rhineland-Palatinate, Germany, 76761
- Owner or operator
- EIZO GmbH (10022828)
- Roles
- Manufacturer
- First device listed
- November 15, 2011
- Registered through
- 2026
- Brand names listed
- CuratOR EX4342, CuratOR EX4342-3D (with 3D glasses H3G01 or H3G02), CuratOR EX4942, CuratOR EX5542, CuratOR EX5841, EX5841-KS, RadiForce Large Monitor System, TM442
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Display, Cathode-Ray Tube, Medical | DXJ | 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 |
|---|---|---|---|---|---|---|
| September 22, 2011 | K112645 | RADIFORCE LARGE MONITOR SYSTEM | DXJ | Substantially Equivalent | Eizo GmbH | accessdata.fda.gov |
Compare with other makers
Updated September 22, 2011. 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.