This company has registrations in United States, Canada — 2 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 | K041237 | ECHOSAMPLER | 2004-09-08 |
| US | K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | 2001-11-30 |
| US | K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | 2001-11-30 |
| CA | 67580 | GYNOSAMPLER ECHANTILLONNEUR UTERIN / GYNOSAMPLER ENDOMETRIAL SUCTION CURETTE | Class II |
| CA | 86997 | FOLLICLE ASPIRATION NEEDLE | Class II |
| CA | 87442 | THE TULIP EMBRYO TRANSFER CATHETER | Class II |