This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel, Russia — 7 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.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | 2023-05-05 |
| US | K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | 2022-10-13 |
| US | K203626 | SureStrip Vitrification Straw, SureLock Vitrification Straw | 2021-06-04 |
| BR | 80370829022 | Evacuador de Bexiga TUR-VAC | Class II |
| BR | 80370829023 | Evacuador de Bexiga Ellick | Class II |
| BR | 80370829024 | Stents Ureterais Pigtail Duplo | Class II |