This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Israel — 6 overseas markets. The China NMPA lookup is still pending.
Saudi Arabia, Singapore, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K243894 | F88 URE-SD/RD Flexible Ureteroscope | 2025-05-02 |
| US | K192518 | Reusable Monopolar Active Cord | 2019-10-25 |
| US | K180731 | Ultramatrix EUS Balloon | 2018-04-19 |
| BR | 10259750019 | Alça com Rede para Coleta de Corpos Estranhos ou Espécimes Roth Neth | Class II |
| BR | 10259750018 | CATA PÓLIPOS | Class II |
| BR | 10259750020 | Pinça guiada por fio Histoguide | Class II |
| CA | 64824 | DISPOSABLE NAKAO SNARE | Class II |
| CA | 64820 | DISPOSABLE HOT BIOPSY FORCEPS | Class II |
| CA | 64822 | REUSABLE BIOPSY FORCEPS | Class II |
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