SonoSite M-Turbo

The SonoSite Regulatory & Compliance web pages provide SonoSite customers information on key elements of medical device compliance.

Regulatory Compliance

WEEE

WEEE RECYCLING INFORMATION
SonoSite believes in environmentally responsible recycling of our products. Here you will find information and guidelines on how to recycle SonoSite products.

WEEE Compliance
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 System

Trade Names:

SonoSite M-Turbo™ Ultrasound System

DECLARATION OF CONFORMITY



Product name:

SonoSite S Series Ultrasound System

Trade Names:

SonoSite S-Nerve™ Ultrasound System
SonoSite 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 system

DECLARATION OF CONFORMITY



Product name:

SonoSite high-resolution ultrasound system (C2 Series)

Trade Names:

TITAN® high-resolution mobile ultrasound system

DECLARATION OF CONFORMITY



Product name:

SonoSite ultrasound system (Power Series)

Trade Names:

SonoSite® iLook Personal Imaging Tool, C15
SonoSite® iLook Personal Imaging Tool, L25

DECLARATION OF CONFORMITY



Product name:

SonoSite hand-carried ultrasound system

Trade Names:

SonoSite® 180PLUS
SonoHeart® ELITE

DECLARATION OF CONFORMITY



Product name:

L25 Needle Guide and Bracket Kit

Trade Names:

L25 Needle Guide and Bracket Kit

DECLARATION OF CONFORMITY