This company has registrations in United States, Brazil, Saudi Arabia, Canada, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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 | K253808 | AIR Recon DL | 2026-08-13 |
| US | K253560 | Enhanced Boundary for PCCT | 2026-06-24 |
| US | K253502 | Critical Care Suite with Enteric Tube Positioning AI Algorithm | 2026-04-14 |
| BR | 80071260348 | Sistema Signa. Modelo: Signa PET/MR | Class II |
| BR | 80071260389 | Sistema de Ultrassom Venue | Class II |
| BR | 80071269019 | Sistema de Imagem por Ressonância Magnética | Class II |
| CA | 37797 | ORTHONE | Class II |
| CA | 36816 | DISCOVERY LS PET-CT SCANNER | Class III |
| CA | 65733 | DISCOVERY ST16-PET-CT IMAGING SYSTEM | Class III |
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