Data / Medical devices / Estonia
Medical device makers in Estonia: 6 FDA-registered establishments
6 establishments in Estonia are registered with the FDA to make medical devices for the US market, listing 52 device types. 2 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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- EstoniaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | 2 |
| Laparoscope, General & Plastic Surgery | GCJ | 1 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 1 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | 1 |
| Bronchoscope (Flexible Or Rigid) | EOQ | 1 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 1 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | 1 |
| Tonometer, Manual | HKY | 1 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 |
| Cover, Mattress (Medical Purposes) | FMW | 1 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 1 |
| Filter, Bacterial, Breathing-Circuit | CAH | 1 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 1 |
| Mask, Gas, Anesthetic | BSJ | 1 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 1 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 |
| Table, Operating-Room, Electrical | GDC | 1 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 1 |
| Laparoscope, Gynecologic (And Accessories) | HET | 1 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered | OCZ | 1 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 1 |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 |
| Otoscope | ERA | 1 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | 1 |
| Endoscope, Neurological | GWG | 1 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 1 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 |
| Table, Surgical With Orthopedic Accessories, Ac-Powered | JEA | 1 |
| Table, Radiologic | KXJ | 1 |
| Laryngoscope, Non-Rigid | CAL | 1 |
| Ventilatory Effort Recorder | MNR | 1 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 1 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 1 |
| Stimulator, Nerve, Peripheral, Electric | KOI | 1 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | 1 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | 1 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | 1 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | 1 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | 1 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | 1 |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 1 |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | 1 |
| Light Source, Endoscope, Xenon Arc | GCT | 1 |
| Cystourethroscope | FBO | 1 |
| Esophagoscope (Flexible Or Rigid) | EOX | 1 |
| Light Source System, Diagnostic Endoscopic | OAY | 1 |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 1 |
| Computer, Oxygen-Uptake | BZL | 1 |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | 1 |
| Stethoscope, Electronic | DQD | 1 |
| Camera, Ophthalmic, General-Use | PJZ | 1 |
| Device, Muscle Monitoring | KZM | 1 |
Makers in Estonia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Pharma Systems Eesti OU | Riidakula Hiiumaa, Estonia | 2 | 4 | 0 | 0 | api.fda.gov |
| Innokas Medical Estonia Ou | Tallinn Harjumaa, Estonia | 11 | 1 | 0 | 0 | api.fda.gov |
| Gabriel Scientific OU | Parnu linn Parnumaa, Estonia | 4 | 0 | 0 | 0 | api.fda.gov |
| Karl Storz Video Endoscopy Estonia Oue | Laagri Harjumaa, Estonia | 20 | 0 | 0 | 0 | api.fda.gov |
| RAUMEDIC Estonia AS | Tallinn Harjumaa, Estonia | 15 | 0 | 0 | 0 | api.fda.gov |
| Tarmetec OU | Tartu Tartumaa, Estonia | 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.