This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 8 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.
Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K170853 | InnoSpire Go | 2017-11-02 |
| US | K102454 | I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM | 2011-10-25 |
| US | K092835 | COMFORTGEL NASAL MASK | 2010-02-12 |
| BR | 10216710248 | PERSONAL BEST MEDIDOR DE FLUXO. | Class I |
| BR | 10216719013 | PROCHAMBER. | Class I |
| BR | 10216710247 | THRESHOLD - DISPOSITIVO PARA TREINAMENTO MUSCULAR RESPIRATÓRIO E PARA | Class I |
| SA | ME0000000594SFDAA00001 | OptiChamber Diamond | — |
| SA | ME0000000933SFDAA00002 | OptiChamber Diamond anti-static valved holding chamber | — |
| CA | 71100 | PRODOSE NEBULIZER SYSTEM | Class II |
| CA | 70599 | PRODOSE NEBULIZER SYSTEM | Class II |
| CA | 1998 | OPTIVENT IN-LINE MDI SPACER | Class II |