Data / Medical devices / Slovenia / Meridian Medical d.o.o.
Meridian Medical d.o.o.: FDA-registered device maker in Ljubljana-Sentvid, Slovenia, 3 510(k) clearances
Meridian Medical d.o.o. is registered with the FDA (registration 3029221947) in Ljubljana-Sentvid, Slovenia. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated January 25, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029221947
- Address
- Plemljeva ulica 8, Ljubljana-Sentvid, Slovenia, 1210
- Owner or operator
- MERIDIAN AG (8030988)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 12, 2008
- Registered through
- 2026
- Brand names listed
- MR Q, MR Q SLT, MR Q Supine, Merilas 532 alpha, Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Manufacturer, 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 25, 2024 | K232417 | MR Q; MR Q SUPINE; MR Q SLT | HQF | Substantially Equivalent | Meridian AG | accessdata.fda.gov |
| September 12, 2023 | K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | HQF | Substantially Equivalent | Meridian AG | accessdata.fda.gov |
| December 14, 2007 | K072823 | MERILAS 532A | HQF | Substantially Equivalent | Meridian AG | accessdata.fda.gov |
Compare with other makers
Updated January 25, 2024. 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.