This company has registrations in United States, Brazil, Canada — 3 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 | K173738 | Archworx | 2021-02-26 |
| US | K143424 | UTAH CVX-RIPE | 2015-08-28 |
| US | K123310 | FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) | 2013-01-23 |
| BR | 80160400014 | LUMIN - MANIPULADOR UTERINO | Class I |
| BR | 80160400015 | PATHFINDER PLUS - SISTEMA DE IRRIGACAO HISTEROSCOPICO | Class I |
| BR | 10289680080 | Introdutor para cateter tipo peel away Utah Medical | Class II |
| CA | 9103 | FEEDING TUBE | Class II |
| CA | 9117 | LIBERTY SYSTEM | Class II |
| CA | 9436 | PALATE PROTECTION FOR NEONATES | Class II |