This company has registrations in European Union, United States — 2 overseas markets. EU UDI-DI records ≥2, the first 300 verified individually. 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 |
|---|---|---|---|
| EU | 03770021637000 | Satelia® Cardio | Class I |
| EU | 03770021637062 | Satelia® Cardio | Class IIa |
| US | K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | 2025-12-04 |
| US | K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector | 2023-04-19 |
| US | K221518 | NP Medical nCompass Extension Set with Stabilizing Base | 2022-11-03 |