Data / Medical devices / Bulgaria
Medical device makers in Bulgaria: 13 FDA-registered establishments
13 establishments in Bulgaria are registered with the FDA to make medical devices for the US market, listing 73 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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- BulgariaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 |
| Laparoscope, General & Plastic Surgery | GCJ | 2 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 |
| System, Surgical, Computer Controlled Instrument | NAY | 2 |
| System, Suction, Lipoplasty For Removal | QPB | 1 |
| System, X-Ray, Angiographic | IZI | 1 |
| Arthroscope | HRX | 1 |
| Light Source, Fiberoptic, Routine | FCW | 1 |
| Hysteroscope (And Accessories) | HIH | 1 |
| Powered Laser Surgical Instrument | GEX | 1 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 1 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 1 |
| Needle, Aspiration And Injection, Disposable | GAA | 1 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 1 |
| Splint, Hand, And Components | ILH | 1 |
| Bandage, Elastic | FQM | 1 |
| Vibrator, Therapeutic | IRO | 1 |
| Lamp, Infrared, Therapeutic Heating | ILY | 1 |
| Automated Radiological Image Processing Software | QIH | 1 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 1 |
| Continuous Measurement Thermometer | FLL | 1 |
| Electrocardiograph | DPS | 1 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | 1 |
| Kit, Nephroscope | FGA | 1 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 1 |
| Led Light Source | NTN | 1 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Joint, Knee, External Brace | ITQ | 1 |
| Brush, Scrub, Operating-Room | GEC | 1 |
| Components, Wheelchair | KNN | 1 |
| Pad, Menstrual, Unscented | HHD | 1 |
| Orthosis, Lumbo-Sacral | IPY | 1 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 1 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 1 |
| Tampon, Menstrual, Unscented | HEB | 1 |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 |
| Oximeter | DQA | 1 |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 1 |
| Cover, Limb | IPM | 1 |
| Orthosis, Limb Brace | IQI | 1 |
| Source, Carrier, Fiberoptic Light | EQH | 1 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 1 |
| Confocal Optical Imaging | OWN | 1 |
| Recorder, Paper Chart | DSF | 1 |
| Joint, Ankle, External Brace | ITW | 1 |
| Component, External, Limb, Ankle/Foot | ISH | 1 |
| Support, Arm | IOY | 1 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | 1 |
| Detector And Alarm, Arrhythmia | DSI | 1 |
| Full-Montage Standard Electroencephalograph | GWQ | 1 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 1 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 1 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 1 |
| System, Isokinetic Testing And Evaluation | IKK | 1 |
| Lift, Patient, Non-Ac-Powered | FSA | 1 |
| Obturator, For Endoscope | FEC | 1 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 1 |
| Table, Powered | INQ | 1 |
| Stimulator, Muscle, Powered, Dental | NUW | 1 |
| Device, Prosthesis Alignment | IQO | 1 |
| Prosthesis, Thigh Socket, External Component | ISS | 1 |
| Stimulator, Muscle, Powered | IPF | 1 |
| Stimulator, Auditory, Evoked Response | GWJ | 1 |
| Device, Galvanic Skin Response Measurement | GZO | 1 |
| Lift, Patient, Ac-Powered | FNG | 1 |
| Transcranial Magnetic Stimulator | OBP | 1 |
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | QCI | 1 |
| Joint, Knee, External Limb Component | ISY | 1 |
| Electromagnetic Stimulator, Pain Relief | QPL | 1 |
| Valve, Prosthesis | ISP | 1 |
| Normalizing Quantitative Electroencephalograph Software | OLU | 1 |
Makers in Bulgaria
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Saint Jones Management LP Eood | Sofia Sofia-Grad, Bulgaria | 68 | 64 | 0 | 0 | api.fda.gov |
| BTL Industries JSC | Plovdiv, Bulgaria | 14 | 28 | 0 | 0 | api.fda.gov |
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | 14 | 8 | 0 | 0 | api.fda.gov |
| Smart Soft Healthcare | Varna, Bulgaria | 1 | 2 | 0 | 0 | api.fda.gov |
| HOYA Corporation | Plovdiv, Bulgaria | 1 | 1 | 0 | 0 | api.fda.gov |
| Intuitive Surgical Bulgaria EOOD | Parvomay Plovdiv, Bulgaria | 2 | 1 | 0 | 0 | api.fda.gov |
| Tampon Innovations | Sofia Sofia-Grad, Bulgaria | 3 | 1 | 0 | 0 | api.fda.gov |
| Aps Trading Ood | Botevgrad Sofia, Bulgaria | 1 | 0 | 0 | 0 | api.fda.gov |
| Apyx Bulgaria Ltd. | Sofia, Bulgaria | 3 | 0 | 0 | 0 | api.fda.gov |
| Cocoon Medical International, Ltd | Sofia, Bulgaria | 1 | 0 | 0 | 0 | api.fda.gov |
| Ottobock Manufacturing Bulgaria EOOD | Blagoevgrad, Bulgaria | 14 | 0 | 0 | 0 | api.fda.gov |
| Schoelly-Optix Ood | Panagyurishte Pazardzhik, Bulgaria | 17 | 0 | 0 | 0 | api.fda.gov |
| SHL Healthcare Ead | Sofia Sofia-Grad, Bulgaria | 2 | 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.