Data / Medical devices / Hungary
Medical device makers in Hungary: 46 FDA-registered establishments
46 establishments in Hungary are registered with the FDA to make medical devices for the US market, listing 209 device types. 24 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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- HungaryCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | 2 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 2 |
| Bottle, Collection, Vacuum | KDQ | 2 |
| Forceps, General & Plastic Surgery | GEN | 2 |
| Retractor | GAD | 2 |
| Scissors, General, Surgical | LRW | 2 |
| Tray, Surgical, Instrument | FSM | 2 |
| Massager, Therapeutic, Electric | ISA | 2 |
| Clamp | HXD | 2 |
| System, Image Processing, Radiological | LLZ | 2 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | 2 |
| Catheter, Straight | EZD | 2 |
| Screw, Fixation, Bone | HWC | 1 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 1 |
| Arthroscope | HRX | 1 |
| Bit, Drill | HTW | 1 |
| Instrument, Manual, Surgical, General Use | MDM | 1 |
| Dressing, Wound, Drug | FRO | 1 |
| Plate, Fixation, Bone | HRS | 1 |
| Cement, Bone, Vertebroplasty | NDN | 1 |
| Rod, Fixation, Intramedullary And Accessories | HSB | 1 |
| Rasp | HTR | 1 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 1 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | 1 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 |
| Calibrator, Multi-Analyte Mixture | JIX | 1 |
| Calibrator, Secondary | JIT | 1 |
| Glucose Oxidase, Glucose | CGA | 1 |
| Electrode, Ion Specific, Potassium | CEM | 1 |
| Electrode, Ion-Specific, Chloride | CGZ | 1 |
| Electrode, Ion Specific, Sodium | JGS | 1 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 1 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | 1 |
| Alkaline Picrate, Colorimetry, Creatinine | CGX | 1 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | 1 |
| Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | KLI | 1 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | 1 |
| Counter, Differential Cell | GKZ | 1 |
| Products, Red-Cell Lysing Products | GGK | 1 |
| General Purpose Reagent | PPM | 1 |
| Electrode, Ion Specific, Calcium | JFP | 1 |
| Electrode, Ion Specific, Urea Nitrogen | CDS | 1 |
| Clamp, Vascular | DXC | 1 |
| Curette | HTF | 1 |
| Needle, Hypodermic, Single Lumen | FMI | 1 |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 |
| Knife, Orthopedic | HTS | 1 |
| Implant, Endosseous, Root-Form | DZE | 1 |
| Abutment, Implant, Dental, Endosseous | NHA | 1 |
| Instrument, Surgical, Non-Powered | HAO | 1 |
| Hysteroscope (And Accessories) | HIH | 1 |
| Catheters, Suction, Tracheobronchial | BSY | 1 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | 1 |
| Holder, Needle; Orthopedic | HXK | 1 |
| Accessories, Implant, Dental, Endosseous | NDP | 1 |
| Unit, Cryosurgical, Accessories | GEH | 1 |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 |
| Syringe, Antistick | MEG | 1 |
| Insufflator, Hysteroscopic | HIG | 1 |
| Instruments, Surgical, Cardiovascular | DWS | 1 |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 |
| Tubes, Gastrointestinal (And Accessories) | KNT | 1 |
| Tape, Measuring, Rulers And Calipers | FTY | 1 |
| Curette, Surgical, General Use | FZS | 1 |
| Lavage, Jet | FQH | 1 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 |
| Lens, Contact, (Disposable) | MVN | 1 |
| Lenses, Soft Contact, Daily Wear | LPL | 1 |
| Splint, Hand, And Components | ILH | 1 |
| Accessories, Retractor, Dental | EIF | 1 |
| Forceps | HTD | 1 |
| Container, Specimen, Non-Sterile | NNI | 1 |
| Toothbrush, Powered | JEQ | 1 |
| Toothbrush, Manual | EFW | 1 |
| Fiber, Medical, Absorbent | FRL | 1 |
| Dressing, Wound, Occlusive | NAD | 1 |
| Lamp, Infrared, Therapeutic Heating | ILY | 1 |
| Handle, Scalpel | GDZ | 1 |
| Holder, Needle, Gastroenterologic | FHQ | 1 |
| Spatula, Surgical, General & Plastic Surgery | GAF | 1 |
| Gag, Mouth | KBN | 1 |
| Forceps, Tooth Extractor, Surgical | EMG | 1 |
| Mallet | HXL | 1 |
| Rasp, Surgical, General & Plastic Surgery | GAC | 1 |
| Chisel, Surgical, Manual | FZO | 1 |
| Saw | HSO | 1 |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 |
| Elevator | HTE | 1 |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 1 |
| Ventilator, Continuous, Facility Use | CBK | 1 |
| Curette, Uterine | HCY | 1 |
| Speculum, Vaginal, Metal | HDF | 1 |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 |
| Mirror, Ent | KAI | 1 |
| Forceps, Ophthalmic | HNR | 1 |
| Scissors, Nasal | KBD | 1 |
| Curette, Ear | JYG | 1 |
Makers in Hungary
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Diamond Diagnostics Inc. | Budapest, Hungary | 241 | 124 | 0 | 0 | api.fda.gov |
| Coloplast Hungary KFT | NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary | 9 | 15 | 0 | 0 | api.fda.gov |
| Tuttnauer Kft. | Dunakeszi Pest, Hungary | 1 | 13 | 0 | 0 | api.fda.gov |
| Coloplast Hungary KFT | TATABANYA Komarom-Esztergom, Hungary | 13 | 9 | 0 | 0 | api.fda.gov |
| Varian Medical Systems Hungary Kft. | Budapest, Hungary | 3 | 8 | 0 | 0 | api.fda.gov |
| CooperVision CL KFT | Gyal Budapest, Hungary | 2 | 5 | 0 | 0 | api.fda.gov |
| Safegard Medical (hungary), Ltd. | FARKASLYUK Borsod-Abauj-Zemplen, Hungary | 2 | 3 | 0 | 0 | api.fda.gov |
| XBody Hungary Zrt. | Gyor, Hungary | 1 | 3 | 0 | 0 | api.fda.gov |
| Zeto EU Kft. | Szeged, Hungary | 2 | 3 | 0 | 0 | api.fda.gov |
| GE Healthcare Magyarorszag Kft. | Budapest, Hungary | 2 | 2 | 0 | 0 | api.fda.gov |
| Hyginett Hungarian American Co. For The Production | CSOMOR Pest, Hungary | 4 | 2 | 0 | 0 | api.fda.gov |
| Meditech KFT. | Budapest, Hungary | 1 | 2 | 0 | 0 | api.fda.gov |
| S.G.S. International Ltd | Budapest, Hungary | 4 | 2 | 0 | 0 | api.fda.gov |
| Coloplast Hungary, KFT | Tatabanya, Hungary | 13 | 1 | 0 | 0 | api.fda.gov |
| Diatron MI Plc | Budapest, Hungary | 7 | 1 | 0 | 0 | api.fda.gov |
| Emd Endoszkop Muszer Gyarto Es Kereskedelmi KFT. | Debrecen Hajdu-Bihar, Hungary | 1 | 1 | 0 | 0 | api.fda.gov |
| Kerox KFT. | Soskut Pest, Hungary | 1 | 1 | 0 | 0 | api.fda.gov |
| Labtech Kereskedelmi Es Mernoki Szolgaltato KFT | Debrecen Hajdu-Bihar, Hungary | 1 | 1 | 0 | 0 | api.fda.gov |
| Lighttech Ltd. | DUNAKESZI Pest, Hungary | 1 | 1 | 0 | 0 | api.fda.gov |
| MAM Hungária Kft. | Vaskeresztes, Hungary | 7 | 1 | 0 | 0 | api.fda.gov |
| MEDISO Ltd.. | Budapest, Hungary | 1 | 1 | 0 | 0 | api.fda.gov |
| Procter & Gamble Hyginett Kft. | Gyongyos Heves, Hungary | 2 | 1 | 0 | 0 | api.fda.gov |
| QX World KFT | Budapest, Hungary | 2 | 1 | 0 | 0 | api.fda.gov |
| SANATMETAL Ltd. | Eger, Hungary | 3 | 1 | 0 | 0 | api.fda.gov |
| 77 Elektronika KFT. | Budapest, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| Attract KFT. | Pecsvarad Baranya, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical, Ltd. | GYONGYOS Heves, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Beurer-Hungaria Ltd.. | Veszprem Veszprem(Urban County), Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Chrisofix Hungary KFT. | Budapest, Hungary | 5 | 0 | 0 | 0 | api.fda.gov |
| Digiterm Ltd. | Gyongyos Heves, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Fetzer Medical Hungaria KFT. | Hosszupalyi Hajdu-Bihar, Hungary | 7 | 0 | 0 | 0 | api.fda.gov |
| Flextronics International Kft | Budapest, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Greiner Bio-One Hungary KFT | MOSONMAGYAROVAR Gyor-Moson-Sopron, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| L Z Form KFT | Ajka Veszprem(County), Hungary | 8 | 0 | 0 | 0 | api.fda.gov |
| Lenyo World Ltd | Budapest, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| Medres Medical Engineering Ltd. | Biatorbagy Pest, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| Mitsubishi Chemical Advanced Materials Kft. | Szigetszentmiklos Budapest, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| Momert Zrt. | Dunaujvaros Fejer, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Nowtechnologies Ltd | Budapest, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Origin Medical Devices Hungary KFT | Vac Pest, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| Oxford Medical Instruments Limited | Szentendre, HU-PE Budapest, Hungary | 3 | 0 | 0 | 0 | api.fda.gov |
| Pharmico Medical Kft. | Debrecen Hajdu-Bihar, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| SFS Group Hungary KFT. | Janossomorja Gyor-Moson-Sopron, Hungary | 1 | 0 | 0 | 0 | api.fda.gov |
| SUBAN Instruments Hungary Co. | DEBRECEN Hajdu-Bihar, Hungary | 80 | 0 | 0 | 0 | api.fda.gov |
| Tipton Global kft | Budapest, Hungary | 2 | 0 | 0 | 0 | api.fda.gov |
| Urosystem ZRT | Budapest, Hungary | 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.