EUROPEAN REGULATORY INFORMATION
The devices identified on this website must be administered by a healthcare professional and are classified in the European Union per Medical Device Directive 93/42/EEC in the classes below, CE 1434.
Please refer to the instructions for use accompanying each product for its indications, contraindications, warnings, precautions, instructions and other information.
| Product |
EU MDD Class |
| Applied Scope-Warmer System |
I |
| UroWIRE |
I |
| Sureseal |
I |
| AeroStat |
I |
| Alexis |
IIa |
| Epix laparoscopic instrumentation |
IIa |
| Forté |
IIa |
| GelPort |
IIa |
| GelPOINT |
IIa |
| GelPOINT Mini |
IIa |
| GelPOINT Path |
IIa |
| GelPOINT V-Path |
IIa |
| Kii |
IIa |
| Insufflation needles |
IIa |
| Inzii |
IIa |
| Stealth |
IIa |
| Voyant |
IIb |
| Silhouette |
IIb |
| Epix laparoscopic instrumentation |
IIb |
| Epix universal clip applier |
IIb |
