This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K262406 | EluPro Antibiotic-Eluting BioEnvelope | 2026-08-12 |
| US | K262165 | FARADRIVE Steerable Sheath (M004PF21M402) | 2026-07-24 |
| US | K262462 | TheraSphere 360 Y-90 Management Platform | 2026-07-24 |
| BR | 10341350268 | CONJUNTO DILATADOR RENAL GRADUADO TIPO AMPLATZ | Class II |
| BR | 10341350478 | SMALL CUTTING BALLOON PERIFERICO | Class II |
| BR | 10341350805 | Percuflex Plus - Stent Ureteral | Class II |
| SA | ME0000000637SFDAA00022 | Seal | — |
| SA | ME0000000537SFDAA00559 | Blox™ | — |
| CA | 4538 | ROLLERBALL | Class II |
| CA | 4613 | CARSON ZERO TIP URETRAL BALLON DILATION CATHETER KIT WITH HYDROPLUS COATING AND GLIDEWIRE | Class II |
| CA | 5237 | CRE WIRE-GUIDED BALLOON DILATATION CATHETER | Class II |