This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia — 5 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 | K221977 | Disposable Surgical Gown (G4003) | 2022-10-20 |
| US | K221196 | Disposable Medical Face Mask (ear loop) | 2022-07-22 |
| US | K211462 | Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask | 2021-08-19 |
| BR | 10330660281 | MÁSCARA TRIPLA ESPECIAL DESCARTÁVEL DESCARPACK | Class I |
| BR | 10330660326 | Macacão de Proteção Descarpack VI | Class I |
| BR | 10330669038 | MÁSCARA CIRÚRGICA DESCARTÁVEL DESCARPACK | Class I |
| SA | ME0000017889SFDAA00003 | Non Woven 3 PLY Face mask | — |
| SA | ME0000012877SFDAA00002 | Medical Isolation Gown | — |