Data / Medical devices / Germany / Vitrolife GmbH
Vitrolife GmbH: FDA-registered device maker in Landshut Bavaria, Germany, 1 510(k) clearance
Vitrolife GmbH is registered with the FDA (registration 3003843927) in Landshut Bavaria, Germany. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 25, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003843927
- Address
- Roedersteinstrasse 6, Landshut Bavaria, Germany, 84034
- Owner or operator
- Vitrolife GmbH (9087379)
- Roles
- Manufacturer
- First device listed
- April 6, 2020
- Registered through
- 2026
- Brand names listed
- Octax LaserShotM, Octax NaviLase
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Assisted Reproduction Laser | MRX | 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 |
|---|---|---|---|---|---|---|
| March 25, 2020 | K192008 | LaserShot M, NaviLase | MRX | Substantially Equivalent | Vitrolife GmbH | accessdata.fda.gov |
Compare with other makers
Updated March 25, 2020. 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.