Data / Medical devices / Romania
Medical device makers in Romania: 12 FDA-registered establishments
12 establishments in Romania are registered with the FDA to make medical devices for the US market, listing 29 device types. 0 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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- RomaniaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 1 |
| Dressing, Wound, Drug | FRO | 1 |
| Orthopedic Stereotaxic Instrument | OLO | 1 |
| Set, Administration, Intravascular | FPA | 1 |
| Pump, Infusion | FRN | 1 |
| Catheter, Urological | KOD | 1 |
| Accessories, Catheter, G-U | KNY | 1 |
| Motor, Drill, Electric | HBC | 1 |
| Point, Abrasive | EHL | 1 |
| Set, I.V. Fluid Transfer | LHI | 1 |
| Tray, Impression, Preformed | EHY | 1 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 1 |
| Humidifier Nebulizer Kit | OGG | 1 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | 1 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 1 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 |
| Transducer, Blood-Pressure, Extravascular | DRS | 1 |
| Amniotome | HGE | 1 |
| Catheter, Urethral | GBM | 1 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 |
| Oximeter | DQA | 1 |
| Material, Impression | ELW | 1 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 1 |
| Denture, Plastic, Teeth | ELM | 1 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | 1 |
| Wheel, Polishing Agent | EJQ | 1 |
| Pump, Infusion, Elastomeric | MEB | 1 |
| Implanted Tibial Electrical Urinary Continence Device | QXM | 1 |
Makers in Romania
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Celestica (romania) SRL | Bors Bihor, Romania | 3 | 0 | 0 | 0 | api.fda.gov |
| Cicor Medtec Bucharest | Bucharest Bucuresti, Romania | 2 | 0 | 0 | 0 | api.fda.gov |
| D & D Politec SRL | Caransebes Caras-Severin, Romania | 2 | 0 | 0 | 0 | api.fda.gov |
| Hamilton Central Europe | Giarmata Timis, Romania | 3 | 0 | 0 | 0 | api.fda.gov |
| Hennig Enterprises Europe S.R.L. | Iasi, Romania | 8 | 0 | 0 | 0 | api.fda.gov |
| Kulzer SRL | Sacalaz-Judet Timis, Romania | 4 | 0 | 0 | 0 | api.fda.gov |
| Laropharm | Magurele Ilfov, Romania | 1 | 0 | 0 | 0 | api.fda.gov |
| Millennium Utility SRL | Marmatiei, Romania | 2 | 0 | 0 | 0 | api.fda.gov |
| Plexus Services Ro SRL | Oradea Bihor, Romania | 1 | 0 | 0 | 0 | api.fda.gov |
| SC Euromedica SRL | Iasi, Romania | 1 | 0 | 0 | 0 | api.fda.gov |
| SC Filtroptic SRL | MINTIA Hunedoara, Romania | 1 | 0 | 0 | 0 | api.fda.gov |
| Textile Medicale | Arad, Romania | 8 | 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.