This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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 | K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | 2025-12-12 |
| US | K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | 2025-11-24 |
| US | K202510 | AMG PMP Infant | 2021-12-10 |
| BR | 81387390011 | Redutor de Pressão para Sprink | Class I |
| BR | 81387390014 | Sistema A.L.ONE para ECMO Pediátrico | Class II |
| BR | 81387390015 | Sistema A.L.ONE para ECMO Neonatal | Class II |
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