Data / Medical devices / Czechia
Medical device makers in Czechia: 40 FDA-registered establishments
40 establishments in Czechia are registered with the FDA to make medical devices for the US market, listing 148 device types. 12 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- CzechiaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 4 |
| Dressing, Compression | MHW | 4 |
| Introducer, Catheter | DYB | 3 |
| Bandage, Elastic | FQM | 3 |
| Anesthesia Conduction Kit | CAZ | 3 |
| Catheter, Conduction, Anesthetic | BSO | 3 |
| Wire, Guide, Catheter | DQX | 2 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 |
| Catheter, Percutaneous | DQY | 2 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | CBI | 2 |
| Accessories, Catheter | KGZ | 2 |
| Catheter, Hemodialysis, Non-Implanted | MPB | 2 |
| Mattress, Air Flotation, Alternating Pressure | FNM | 2 |
| Catheter, Flow Directed | DYG | 2 |
| Generator, Oxygen, Portable | CAW | 2 |
| Catheter, Subclavian | LFJ | 2 |
| Stimulator, Muscle, Powered | IPF | 2 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 1 |
| Insufflator, Laparoscopic | HIF | 1 |
| Syringe, Piston | FMF | 1 |
| Laparoscope, General & Plastic Surgery | GCJ | 1 |
| Arthroscope | HRX | 1 |
| Instrument, Special Lens, For Endoscope | FEI | 1 |
| Camera, Surgical And Accessories | KQM | 1 |
| Instrument, Manual, Surgical, General Use | MDM | 1 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | 1 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 1 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 1 |
| Light Source, Fiberoptic, Routine | FCW | 1 |
| Radioimmunoassay, Estradiol | CHP | 1 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | 1 |
| Reagents, Specific, Analyte | MVU | 1 |
| Probe, Uptake, Nuclear | IZD | 1 |
| Peripheral Catheter Insertion Kit | OWL | 1 |
| Abutment, Implant, Dental, Endosseous | NHA | 1 |
| Device, Monitoring, Intracranial Pressure | GWM | 1 |
| Catheter, Intravascular, Diagnostic | DQO | 1 |
| Electrode, Needle | GXZ | 1 |
| Bottle, Collection, Vacuum | KDQ | 1 |
| Hysteroscope (And Accessories) | HIH | 1 |
| Tube, Tracheal (W/Wo Connector) | BTR | 1 |
| Electrode, Electrosurgical | JOS | 1 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 1 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 1 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 1 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 1 |
| Biopsy Needle | FCG | 1 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | 1 |
| Insufflator, Hysteroscopic | HIG | 1 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 |
| Electrode, Electrosurgical, Active, Urological | FAS | 1 |
| Catheter, Irrigation | GBX | 1 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 1 |
| Curette, Surgical, General Use | FZS | 1 |
| Point, Abrasive | EHL | 1 |
| Set, I.V. Fluid Transfer | LHI | 1 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 1 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | 1 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | 1 |
| Drape, Surgical, Exempt | PUI | 1 |
| Bandage, Cast | ITG | 1 |
| Instruments, Dental Hand | DZN | 1 |
| Lubricant, Patient | KMJ | 1 |
| Garment, Protective, For Incontinence | EYQ | 1 |
| Holder, Film, X-Ray | EGZ | 1 |
| Lamp, Infrared, Therapeutic Heating | ILY | 1 |
| Retractor, All Types | EIG | 1 |
| Clamp, Rubber Dam | EEF | 1 |
| Punch, Surgical | LRY | 1 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 |
| Stocking, Elastic | ILG | 1 |
| Bed, Ac-Powered Adjustable Hospital | FNL | 1 |
| Snare, Flexible | FDI | 1 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 1 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | 1 |
| Dilator, Catheter | GCC | 1 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | 1 |
| Device, Cystometric, Hydraulic | FEN | 1 |
| Laparoscope, Gynecologic (And Accessories) | HET | 1 |
| Bag, Intestine | KGY | 1 |
| Collector, Ostomy | EXB | 1 |
| Probe, Thermodilution | KRB | 1 |
| Probe, Radiofrequency Lesion | GXI | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Joint, Knee, External Brace | ITQ | 1 |
| Resectoscope | FJL | 1 |
| Chair And Table, Medical | KMN | 1 |
| Material, Tooth Shade, Resin | EBF | 1 |
| Material, Impression | ELW | 1 |
| Cord, Retraction | MVL | 1 |
| Activator, Ultraviolet, For Polymerization | EBZ | 1 |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 |
| Disk, Abrasive | EHJ | 1 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 |
| Epidural Anesthesia Kit | OGE | 1 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 |
| Regulator, Pressure, Gas Cylinder | CAN | 1 |
Makers in Czechia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Arrow International C.R. a.s. | ZDAR NAD SAZAVOU Vysocina, Czechia | 50 | 105 | 0 | 0 | api.fda.gov |
| Arrow International CR, a.s. | Hradec Kralove, Czechia | 23 | 47 | 0 | 0 | api.fda.gov |
| Novanta Medical S.R.O. | Prelouc Pardubicky Kraj, Czechia | 15 | 15 | 0 | 0 | api.fda.gov |
| Olympus Medical Products Czech | Prerov II Predmosti, Czechia | 7 | 15 | 0 | 0 | api.fda.gov |
| IMMUNOTECH s.r.o. | Prague Praha, Hlavni Mesto, Czechia | 6 | 7 | 0 | 2 | api.fda.gov |
| Resorba, s.r.o | Domazlice, Czechia | 7 | 4 | 0 | 0 | api.fda.gov |
| COMPEX, spol. s r.o. | Brno Mesto Brno, Czechia | 2 | 3 | 0 | 0 | api.fda.gov |
| SpofaDental a.s. | Jicin, Czechia | 10 | 3 | 0 | 0 | api.fda.gov |
| ADM, a.s. | Brno Mesto Brno, Czechia | 1 | 1 | 0 | 0 | api.fda.gov |
| Drylock Technologies S.R.O. | Hradek nad Nisou Liberecky Kraj, Czechia | 1 | 1 | 0 | 0 | api.fda.gov |
| Medicem Technology s.r.o | Kamenne Zehrovice Stredocesky Kraj, Czechia | 1 | 1 | 0 | 0 | api.fda.gov |
| Rodenstock CR S.R.O. | Plzensky Klatovy, Czechia | 3 | 1 | 0 | 0 | api.fda.gov |
| Alp Ecology S.R.O. | Ostrava - Privoz Ostrava-Mesto, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| Aveflor | Kopidlno Jicin, Czechia | 2 | 0 | 0 | 0 | api.fda.gov |
| CIMPAX CZ s.r.o. | Vyskov, Czechia | 2 | 0 | 0 | 0 | api.fda.gov |
| Connectronics S.R.O. | Kladno, Czechia | 3 | 0 | 0 | 0 | api.fda.gov |
| Contract Medical International, Spol. S R.O. | Hradec Kralove, Czechia | 4 | 0 | 0 | 0 | api.fda.gov |
| Deymed Diagnostic S.R.O. | Hronov Nachod, Czechia | 3 | 0 | 0 | 0 | api.fda.gov |
| DINA-HITEX, spol. s r.o. | Bucovice Vyskov, Czechia | 3 | 0 | 0 | 0 | api.fda.gov |
| EH Labs CZ s.r.o. | Dvur Kralove nad Labem Hradec Kralove, Czechia | 3 | 0 | 0 | 0 | api.fda.gov |
| Ella-Cs, S.R.O. | Hradec Kralove, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| Exbio Praha, A.S. | Vestec Praha-Zapad, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| Foxconn European Manufacturing Services S.R.O. | Pardubice, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| GCE, s.r.o. | Chotebor Havlickuv Brod, Czechia | 3 | 0 | 0 | 0 | api.fda.gov |
| Haselmeier s.r.o. | Dnesice Plzen-Sever, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| KH Czechia s.r.o. | Chodov Sokolov, Czechia | 6 | 0 | 0 | 0 | api.fda.gov |
| Lasak S.R.O. | Praha 9 Praha, Hlavni Mesto, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| LINET spol. s r.o. | Slany Stredocesky Kraj, Czechia | 10 | 0 | 0 | 3 | api.fda.gov |
| Lipoelastic A.S. | Prague Praha, Hlavni Mesto, Czechia | 4 | 0 | 0 | 0 | api.fda.gov |
| Lohmann & Rauscher s.r.o | Slavkov u Brna Jihomoravsky Kraj, Czechia | 4 | 0 | 0 | 0 | api.fda.gov |
| Lohmann & Rauscher s.r.o. | Nová Paka Jicin, Czechia | 3 | 0 | 0 | 0 | api.fda.gov |
| Lohmann & Rauscher s.r.o. | Stara Paka Jicin, Czechia | 2 | 0 | 0 | 0 | api.fda.gov |
| Medi-Globe Sro | HRANICE Olomouc, Czechia | 5 | 0 | 0 | 0 | api.fda.gov |
| Medkonsult Medical Technology S.R.O. | Olomouc, Czechia | 2 | 0 | 0 | 0 | api.fda.gov |
| Parabel S.R.O. | Lukov Zlinsky Kraj, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| Purtex S.R.O. | Zdiby Praha-Vychod, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| Schott CR, S.R.O. | Valasske Mezirici Zlinsky Kraj, Czechia | 6 | 0 | 0 | 0 | api.fda.gov |
| Thuasne Czech Republic S.R.O | PREDKLASTERI Brno-Venkov, Czechia | 6 | 0 | 0 | 0 | api.fda.gov |
| Vatpor CZ Spol. S R.O. | Srch Pardubice, Czechia | 1 | 0 | 0 | 0 | api.fda.gov |
| safemed medical devices s.r.o. | Prague Praha, Hlavni Mesto, Czechia | 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.