This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.
Australia, Hong Kong, Saudi Arabia, Singapore, 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 | K262056 | Rusch Latex Gold Foley Catheter | 2026-08-05 |
| US | K261988 | Monodek (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture | 2026-07-09 |
| US | K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | 2026-05-15 |
| BR | 10150470123 | SONDA DE FOLEY SILICONE RUSCH | Class II |
| BR | 80312279076 | Cânula de Traqueostomia CrystalClear com Balão | Class II |
| BR | 80312279040 | Humid-Vent® 1 Port | Class II |
| CA | 99048 | HUDSON RCL COMFORT FLO PLUS CANNULA | Class II |
| CA | 99163 | HUDSON RCI TRACHEOSTOMY ADAPTOR | Class II |
| CA | 5930 | MALECOT AND PEZZER CATHETERS | Class II |
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