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 | K072427 | SIGMA SERIES HYPERBARIC CHAMBER | 2008-06-11 |
| US | K990927 | SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER | 1999-11-12 |
| US | K983648 | SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM | 1999-02-24 |
| CA | 27313 | SIGMA PLUS SERIES HYPERBARIC CHAMBER | Class III |
| CA | 28094 | SIGMA II SERIES HYPERBARIC CHAMBER | Class III |
| CA | 28304 | SIGMA MP SERIES HYPERBARIC CHAMBER | Class III |