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Basic Company Information
Are you a current Intertek client?
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Confirm that the device(s) covered by this application is/are a medical device according to the definition in Article 2, (1) of 2017/745 MDR, ‘Medical Device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Types of devices:
Please select all applicable MDR code(s) covering your product(s) as part of this applications from the check list below.
Non-active non-implantable devices MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care MDN 1202 Non-active non-implantable devices for administration, channeling and removal of substances, including devices for dialysis MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools MDN 1204 Non-active non-implantable devices for wound and skin care MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices Orthoses MDN 1206 Non-active non-implantable ophthalmologic devices MDN 1207 Non-active non-implantable diagnostic devices MDN 1208 Non-active non-implantable instruments MDN 1209 Non-active non-implantable dental materials MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing MDN 1212 Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) MDN 1213 Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route MDN 1214 General non-active non-implantable devices used in health care and other nonactive non-implantable devices