This company has registrations in Brazil, Canada, Singapore, Australia, Israel — 5 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 |
|---|---|---|---|
| BR | 81070509002 | Cateter Ureteral Duplo J Endosil Black Silicone | Class II |
| BR | 80187420010 | Rocastone Kobot Tipless | Class II |
| BR | 81070500003 | Extrator de Cálculos Rocamed RocaStone | Class II |
| CA | 90513 | BIFLEX EVO: URETERAL ACCESS SHEATH | Class II |
| CA | 90514 | ROCAWIRE GOLD: GUIDE ACIER PTFE | Class II |
| CA | 90515 | ROCABALLOON: BALLONS DE DILATATION URETERALE | Class II |