Data / Medical devices / Germany / Xiralite GMBH
Xiralite GMBH: FDA-registered device maker in Berlin, Germany, 1 510(k) clearance
Xiralite GMBH is registered with the FDA (registration 3014321789) in Berlin, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 31, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014321789
- Address
- Robert-Koch-Platz 4, Berlin, Germany, 10115
- Owner or operator
- Xiralite GmbH (10056880)
- Roles
- Manufacturer
- First device listed
- January 26, 2018
- Registered through
- 2026
- Brand names listed
- XIRALITE FLOURESCENCE IMAGING SYSTEM X4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Confocal Optical Imaging | OWN | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Angiographic | IZI | 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 |
|---|---|---|---|---|---|---|
| January 31, 2014 | K130003 | XIRALITE FLOURESCENCE IMAGING SYSTEM X4 | IZI | Substantially Equivalent | Mivenion GmbH | accessdata.fda.gov |
Compare with other makers
Updated January 31, 2014. 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.