This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Israel — 6 overseas markets. The China NMPA lookup is still pending.
Australia, Saudi Arabia, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
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 | K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | 2022-09-29 |
| US | K221027 | Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) | 2022-08-12 |
| US | K220487 | Disposable Medical Face Mask | 2022-04-26 |
| BR | 80517530007 | FITA MICROPOROSA | Class I |
| BR | 80630310014 | MÁSCARA CIRÚRGICA TRIPLA | Class I |
| BR | 82110810018 | MÁSCARA TRIPLA DESCARTÁVEL | Class I |
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