Data / Medical devices / Monaco
Medical device makers in Monaco: 3 FDA-registered establishments
3 establishments in Monaco are registered with the FDA to make medical devices for the US market, listing 20 device types. 1 has 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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- MonacoCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Catheter, Irrigation | GBX | 2 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | 1 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 1 |
| Stent, Ureteral | FAD | 1 |
| Catheter, Ureteral, Gastro-Urology | EYB | 1 |
| Accessories, Catheter, G-U | KNY | 1 |
| Lithotriptor, Ultrasonic | FEO | 1 |
| Dislodger, Stone, Flexible | FGO | 1 |
| Endoscopic Irrigation/Suction System | OCX | 1 |
| Needle, Catheter | GCB | 1 |
| Tube, Aspirating, Flexible, Connecting | BYY | 1 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 1 |
| Device, Cystometric, Hydraulic | FEN | 1 |
| System, Evacuator, Fluid | FHF | 1 |
| Lithotriptor, Electro-Hydraulic | FFK | 1 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 1 |
| Stylet, Ureteral | EYA | 1 |
| Injector, Contrast Medium, Automatic | IZQ | 1 |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 |
Makers in Monaco
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Rocamed Sam | MONACO Monaco-Ville, Monaco | 10 | 8 | 0 | 0 | api.fda.gov |
| Promepla S.A.M | MONACO Monaco-Ville, Monaco | 12 | 0 | 0 | 0 | api.fda.gov |
| Safas | Monaco Monaco-Ville, Monaco | 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.