
The SonoSite Regulatory & Compliance web pages provide SonoSite customers information on key elements of medical device compliance.
Regulatory Compliance
WEEE
SonoSite believes in environmentally responsible recycling of our products. Here you will find information and guidelines on how to recycle SonoSite products.
WEEE REGISTRATION NUMBERS
SonoSite's Registration numbers for European Union WEEE Regulations:
United Kingdom: WEE/GH0078UU
Regulatory & Compliance / Documentation / European Union
To place a medical device on the market within the European Union, CE marking of the device is required and the manufacturer must comply with European Union Medical Device Directive (MDD) - Council Directive 93/42/EEC of 14 June 1993 concerning medical products. SonoSite maintains technical documentation files (TDF) on each device covered by CE marking. The TDF is made available to the notified body or national authorities for Conformity Assessments according to MDD 93/42/EEC Annex II, MDD 93/42/EEC Annex V or MDD 93/42/EEC Annex IX.
For each SonoSite device marketed within the European Union SonoSite prepares a declaration of conformity with the MDD and applies CE marking. For other countries, outside of the European Union, additional documentation is available.
The links below provide copies of declarations of conformity for each product listed.
Product name:
SonoSite M Series Ultrasound SystemTrade Names:
SonoSite M-Turbo™ Ultrasound SystemDECLARATION OF CONFORMITY
Product name:
SonoSite S Series Ultrasound SystemTrade Names:
SonoSite S-Nerve™ Ultrasound SystemSonoSite S-FAST™ Ultrasound System
SonoSite S-ICU™ Ultrasound System
SonoSite S-Cath™ Ultrasound System
DECLARATION OF CONFORMITY
Product name:
SonoSite high-resolution ultrasound system (C3 Series)Trade Names:
MicroMaxx® high-resolution ultrasound systemDECLARATION OF CONFORMITY
Product name:
SonoSite high-resolution ultrasound system (C2 Series)Trade Names:
TITAN® high-resolution mobile ultrasound systemDECLARATION OF CONFORMITY
Product name:
SonoSite ultrasound system (Power Series)Trade Names:
SonoSite® iLook Personal Imaging Tool, C15SonoSite® iLook Personal Imaging Tool, L25
DECLARATION OF CONFORMITY
Product name:
SonoSite hand-carried ultrasound systemTrade Names:
SonoSite® 180PLUSSonoHeart® ELITE
M-Turbo™
S Series™
M-OB/GYN Office
MicroMaxx®
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