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Legal Notice

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

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3815 KL Amersfoort, The Netherlands

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