This company has registrations in United States, Brazil — 2 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 | K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | 2024-07-10 |
| US | K181954 | autoLog IQ Autotransfusion System | 2018-08-22 |
| US | K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | 2013-03-19 |
| BR | 10349000710 | AFFINITY FUSION (BALANCE) - OXIGENADOR COM FILTRO ARTERIAL INTEGRADO E | Class II |
| BR | 10349000771 | SISTEMA RETRATOR THORATRAK | Class II |
| BR | 10349000789 | MEDIDOR AUTOMÁTICO DO TEMPO DE COAGULAÇÃO ACT PLUS | Class II |