Data / Medical devices / Slovakia
Medical device makers in Slovakia: 14 FDA-registered establishments
14 establishments in Slovakia are registered with the FDA to make medical devices for the US market, listing 71 device types. 5 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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- SlovakiaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Garment, Protective, For Incontinence | EYQ | 2 |
| Syringe, Piston | FMF | 1 |
| Apparatus, Traction, Non-Powered | HST | 1 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 |
| Needle, Hypodermic, Single Lumen | FMI | 1 |
| Catheter, Urological | KOD | 1 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 1 |
| Forceps, General & Plastic Surgery | GEN | 1 |
| Transducer, Ultrasonic, Diagnostic | ITX | 1 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 1 |
| Tubes, Gastrointestinal (And Accessories) | KNT | 1 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 1 |
| Knife, Ophthalmic | HNN | 1 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 1 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 |
| Stand, Infusion | FOX | 1 |
| Bandage, Elastic | FQM | 1 |
| Automated Radiological Image Processing Software | QIH | 1 |
| Dilator, Lachrymal | HNW | 1 |
| Probe, Lachrymal | HNL | 1 |
| Forceps, Ophthalmic | HNR | 1 |
| Hook, Ophthalmic | HNQ | 1 |
| Scissors, Ophthalmic | HNF | 1 |
| Spatula, Ophthalmic | HND | 1 |
| Specula, Ophthalmic | HNC | 1 |
| Retractor, Ophthalmic | HNI | 1 |
| Caliper, Ophthalmic | HOE | 1 |
| Ring, Ophthalmic (Flieringa) | HNH | 1 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | 1 |
| Depressor, Orbital | HNX | 1 |
| Gauge, Lens, Ophthalmic | HLN | 1 |
| Spoon, Ophthalmic | HNB | 1 |
| Cystotome | HNY | 1 |
| Curette, Ophthalmic | HNZ | 1 |
| Marker, Sclera | HMQ | 1 |
| Introducer, Sphere | HNP | 1 |
| Rongeur, Lachrymal Sac | HNG | 1 |
| Cannula, Ophthalmic | HMX | 1 |
| Clip, Iris Retractor | HOC | 1 |
| Trephine, Manual, Ophthalmic | HRH | 1 |
| Clamp, Muscle, Ophthalmic | HOB | 1 |
| Clamp, Eyelid, Ophthalmic | HOD | 1 |
| Trabeculotome | HMZ | 1 |
| Probe, Trabeculotomy | HNK | 1 |
| Marker, Ocular | HMR | 1 |
| Device, Irrigation, Ocular Surgery | KYG | 1 |
| Needle, Ophthalmic Suturing | HNM | 1 |
| Punch, Corneo-Scleral | HNJ | 1 |
| Spud, Ophthalmic | HNA | 1 |
| Catheter, Urethral | GBM | 1 |
| Compressor, Air, Portable | BTI | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | 1 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 1 |
| Pouch, Colostomy | EZQ | 1 |
| Protector, Ostomy | EXE | 1 |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 1 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 |
| Stretcher, Hand-Carried | FPP | 1 |
| Catheter, Straight | EZD | 1 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 1 |
| Catheter, Ultrasound, Intravascular | OBJ | 1 |
| Detector And Alarm, Arrhythmia | DSI | 1 |
| Stimulator, Nerve, Peripheral, Electric | KOI | 1 |
| Recorder, Magnetic Tape, Medical | DSH | 1 |
| Biopsy Needle Guide Kit | OIJ | 1 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 |
| Support, Hernia | EXN | 1 |
| Bag, Urinary, Ileostomy | EXH | 1 |
| Binder, Breast | HEF | 1 |
| Alarm, Conditioned Response Enuresis | KPN | 1 |
Makers in Slovakia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Siemens Healthcare s.r.o. | Kosice-Barca Kosicky, Slovakia | 6 | 16 | 0 | 0 | api.fda.gov |
| Chirana T.injecta, A.S. | Stara Tura Trenciansky, Slovakia | 3 | 4 | 0 | 0 | api.fda.gov |
| Unomedical S.R.O. | MICHALOVCE Kosicky, Slovakia | 5 | 3 | 0 | 0 | api.fda.gov |
| Ekom Spol. S R.O. | PIESTANY Trnavsky, Slovakia | 1 | 1 | 0 | 0 | api.fda.gov |
| SKY Medical, a.s. | Samorin Trnavsky, Slovakia | 2 | 1 | 0 | 0 | api.fda.gov |
| Bis Mastermed | Kosice Kosicky, Slovakia | 33 | 0 | 0 | 0 | api.fda.gov |
| Biometrix sro | Samorin Bratislavsky, Slovakia | 1 | 0 | 0 | 0 | api.fda.gov |
| Essity Slovakia s.r.o. | GEMERSKA-HORKA Kosicky, Slovakia | 2 | 0 | 0 | 0 | api.fda.gov |
| Ferno Slovakia s.r.o. | Slovak Republic Trenciansky, Slovakia | 4 | 0 | 0 | 0 | api.fda.gov |
| QUAD Slovakia s.r.o. | Zilina Zilinsky, Slovakia | 1 | 0 | 0 | 0 | api.fda.gov |
| Semecs, S.R.O. | Vrable Nitriansky, Slovakia | 3 | 0 | 0 | 0 | api.fda.gov |
| Stirilab S.R.O. | Ruzomberok Zilinsky, Slovakia | 3 | 0 | 0 | 0 | api.fda.gov |
| Seisa Europe s.r.o. | myjava Trenciansky, Slovakia | 1 | 0 | 0 | 0 | api.fda.gov |
| Tytex Slovakia S.R.O. | HUMENNE Presovsky, Slovakia | 7 | 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.