Company Information Company Registration Digitimer Limited is a registered company in England and Wales under company number 459711. Our VAT Registration No. is GB 196476021. Our EORI (Economic Operator Registration and Identification) No. is GB196476021000 The address of our registered office address is given below:- Suite 501 (PO Box 501), The Nexus Building, Broadway, Letchworth Garden City, SG6 9BL,UK Please note that this address should NOT be used for general correspondence. In order to contact us please use the “Contact Us” tab on the menu bar. WEEE Compliance Statement The European Union has adopted Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE), with requirements that went into effect August 13, 2005. WEEE is intended to reduce the disposal of waste from electrical and electronic equipment by establishing guidelines for prevention, reuse, recycling and recovery. As part of our legal obligation, Digitimer Limited is now a registered EEE producer. Our WEEE registration number is WEE/BJ0052TQ. For further information relating to the correct method of disposal of any of our equipment, which features the label below, please contact us. RoHS Compliance The European Union has adopted Directive 2002/95/EC on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS) which came into effect on 1st July 2006. The RoHS directive is intended to reduce the use and, therefore, the subsequent disposal of environmentally hazardous substances. Digitimer Ltd is fully compliant with the current RoHS regulations. A RoHS declaration is available here:- Declaration of RoHS Compliance (Directive (EU) 2015/863) Registration, Evaluation Authorisation and Restriction of Chemicals (REACH) Under the regulations, Digitimer is a downstream user and producer of Articles. As such we are not required to register any of our products. Any substances used during the manufacture of Digitimer products are sourced from within the European Union and are used in volumes substantially below the 1 tonne per annum registration threshold. A full REACH declaration is available here:- REACH DOWNLOAD Potential Use of Conflict Minerals in Digitimer Products Digitimer does not directly purchase any minerals from any source and does not knowingly procure any products containing conflict minerals (or their derivatives). A signed statement to this effect is provided below:- Conflict Minerals Statement ISO13485 Certification The following regulatory certificates are available for download in PDF format:- ISO13485 SGS Certificate CE Marking Change of Notified Body As of 16th December 2019 the authority for CE marking Digitimer medical devices has moved from SGS United Kingdom (CE0120) to SGS Belgium (CE1639). The change of the CE mark present on devices from CE0120 to CE1639 is planned to take place on newly manufactured products between 16th December 2019 and 15th June 2020. Any product bearing the mark CE0120 has been certified by SGS UK and any product bearing CE1639 has been certified by SGS Belgium. Stocks of products placed on the market bearing the CE0120 mark will be exhausted before products marked with CE1639 are shipped. Any concerns or questions should be referred to Digitimer or SGS.