This company has registrations in United States, Taiwan, Australia, Russia — 4 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 | K172267 | IRENE Thoracolumbar Fixation System | 2018-03-06 |
| US | K170056 | IRENE Cannulated Screw System | 2017-10-23 |
| US | K151508 | IRENE Locking Compression Plate System | 2016-02-25 |