Data / Medical devices / Slovenia
Medical device makers in Slovenia: 14 FDA-registered establishments
14 establishments in Slovenia are registered with the FDA to make medical devices for the US market, listing 35 device types. 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- SloveniaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 |
| Massager, Therapeutic, Electric | ISA | 2 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | 1 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 1 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 1 |
| Lamp, Infrared, Therapeutic Heating | ILY | 1 |
| Electrocardiograph | DPS | 1 |
| Spirometer, Diagnostic | BZG | 1 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 1 |
| System, Pressure Measurement, Intermittent | JFC | 1 |
| Bath, Incubators/Water, All | JTQ | 1 |
| Pad, Menstrual, Unscented | HHD | 1 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 1 |
| Tampon, Menstrual, Unscented | HEB | 1 |
| Light Based Over-The-Counter Hair Removal | OHT | 1 |
| Apparatus, Autotransfusion | CAC | 1 |
| Reservoir, Blood, Cardiopulmonary Bypass | DTN | 1 |
| Crown And Bridge, Temporary, Resin | EBG | 1 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 1 |
| Denture, Plastic, Teeth | ELM | 1 |
| Exerciser, Measuring | ISD | 1 |
| Laser, Ophthalmic | HQF | 1 |
| Monitor, Breathing Frequency | BZQ | 1 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 1 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 1 |
| Sterilizer, Steam | FLE | 1 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 1 |
| System, Planning, Radiation Therapy Treatment | MUJ | 1 |
| Stimulator, Muscle, Powered | IPF | 1 |
| Laser, Dental, Soft Tissue | NVK | 1 |
| Disinfector, Medical Devices | MEC | 1 |
| Pad, Menstrual, Reusable | NUQ | 1 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 1 |
| Electromagnetic Stimulator, Pain Relief | QPL | 1 |
| Oscillometer | DRZ | 1 |
Makers in Slovenia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Fotona D.O.O. | Ljubljana, Slovenia | 9 | 18 | 0 | 0 | api.fda.gov |
| Mesi D.O.O. | Ljubljana, Slovenia | 3 | 5 | 0 | 0 | api.fda.gov |
| Meridian Medical d.o.o. | Ljubljana-Sentvid, Slovenia | 1 | 3 | 0 | 0 | api.fda.gov |
| POLIDENT d.o.o., Dental products industry | VOLCJA DRAGA Rence-Vogrsko, Slovenia | 3 | 3 | 0 | 0 | api.fda.gov |
| TOSAMA d.o.o. | Domzale, Slovenia | 2 | 2 | 0 | 0 | api.fda.gov |
| Cosylab, JCS, Control System Laboratory | Ljubljana, Slovenia | 1 | 1 | 0 | 0 | api.fda.gov |
| Iskra Medical D O O | Podnart Radovljica, Slovenia | 2 | 1 | 0 | 0 | api.fda.gov |
| Belimed D.O.O. | Grosuplje, Slovenia | 2 | 0 | 0 | 0 | api.fda.gov |
| Bioprod D.O.O. | Ljubljana, Slovenia | 3 | 0 | 0 | 0 | api.fda.gov |
| Domel, d.o.o., (Business Unit LABS) | Zelezniki, Slovenia | 2 | 0 | 0 | 0 | api.fda.gov |
| Iskra Mehanizmi D.O.O. | Brnik-Aerodrom, Slovenia | 2 | 0 | 0 | 0 | api.fda.gov |
| L-Tek D.O.O. | Sentjernej Ljubljana, Slovenia | 5 | 0 | 0 | 0 | api.fda.gov |
| MDCN Tech D.O.O. | Ljubljana, Slovenia | 1 | 0 | 0 | 0 | api.fda.gov |
| Viral D.O.O. | Sovodenj Skofja Loka, Slovenia | 1 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.