This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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 | K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) | 2026-07-10 |
| US | K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | 2026-05-29 |
| US | K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | 2026-03-17 |
| BR | 10033430903 | PureWickFlex Cateter Externo Feminino (Acute Care) | Class I |
| BR | 10033439110 | Cesto Extrator de Cálculos em Nitinol sem ponta SkyLite | Class II |
| BR | 10033439111 | Proxis Bainha de Acesso Ureteral | Class II |
| SA | ME0000000931SFDAA00001 | PUREWICK | — |
| CA | 5542 | URETHRAL DILATORS - SOUNDS - STAINLESS STEEL | Class II |
| CA | 7479 | BALLOON DILATION CATHETERS | Class II |
| CA | 71135 | URETHRAL DILATORS - URETHANE FILIFORMS | Class II |