This company has registrations in United States, Brazil, Canada — 3 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 | K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection | 2023-10-06 |
| US | K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit | 2018-10-18 |
| US | K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection | 2017-06-06 |
| BR | 81325540005 | SONDA PARA ALIMENTAÇÃO ENTERAL COM BALÃO - DANDARA | Class II |
| CA | 88219 | STOMA MEASURING DEVICE | Class II |
| CA | 90854 | THORACIC DRAIN SYSTEM | Class II |
| CA | 94927 | ENDOVIVE 3S LOW PROFILE BALLOON KIT | Class III |