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 | K860026 | ULTRAMAX III, DIALYZER REPROCESSING DEVICE | 1986-03-14 |
| US | K844850 | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT | 1985-04-02 |
| US | K832705 | ULTRAMAX | 1984-06-25 |
| CA | 16412 | THS IRMA PHASE SOLIDE / TSH IRMA COATED TUBE | Class II |
| CA | 16413 | HPRL ELISA MICROPLAQUE / HPRL ELISA (PROLACTIN) COATED WELL | Class II |
| CA | 16415 | HGH ELISA MIRCOPLAQUE (MONOCLONAL) / HGH ELISA COATED WELL (MONOCLONAL) | Class II |