Register your Medical Devices (MDs & IVDs)

Name: *
Company Name *
Address: *
E-mail: *
Phone: *
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Contact Person Name *
Contact Person's Title *
Contact person's telephone number *
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Contact email *
Date of commencement of business *
Licenses in place with full details *
Do you have any CE Marking for the product fro which you seek registration *
Do you want us to process your CE Certification also *
Select: *
Mobile (Cell) Phone No
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Is your product a Medical Device (MD) ?
i.e., a kind of instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap. investigation, replacement or modification of the anatomy or of a physiological process. control of conception
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means ?*

Is your product a Medical Device (MD) ? *
If MD, which class?

Is your product In-vitro Diagnostic Medical Device (IVD)?
which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures ?*

Is it In-vitro Diagnostic Medical Device (IVD)
If it is IVD, which category *
Is your product an Active Implantable Medical Device (AIMD) - See explanation below *

Is your product an Active Implantable Medical Device (AIMD)?

i.e., a medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and the device is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure ?*

Is your product a Personal Protective Equipment (PPE) under - Directive 89/686/EEC

Above, i.e., a device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards ?*

Is your product a LVD. See remarks below *

i.e. the kind of equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current (A.C.) and between 75 and 1500 V for direct current (D.C.) ?*

Is your product a machinery?* - See remarks below

The "machinery" means:
an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material,
an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool.

Is your product a Radio Equipment or Telecommunications Terminal Equipment - See remarks below *
A "radio equipment" means a product, or relevant component thereof, capable of communication by means of the emission and/or reception of radio waves utilising the spectrum allocated to terrestrial/space radiocommunications.
A "telecommunications terminal equipment" means a product enabling communication or a relevant component thereof which is intended to be connected directly or indirectly by any means whatsoever to interfaces of public telecommunications networks (that is to say, telecommunications networks used wholly or partly for the provision of publicly available telecommunications services).
Is your product designed or intended, whether or not exclusively, for use in play by children under 14 years of age.
From which date you have started production or want to start production *
Number of employees in your company: *
If you have not obtained the CE Marking for your products,WHEN do you expect to get the CE Marking *
What services are you expecting from UKB *
Upload your incorporation certifiate *
Upload all licenses in one Single PDF *
Textarea: *
3- Give the name & address of your current (or former) Auth Rep. (Use ENTER key to break lines
How many unique models of product would you like to have Wellkang act as the CE Marking Auth Rep for?*
Write the names of models in details
URLs-Webpages1
URLs-Webpages-2
What is/are the name(s) of the product(s)
What is/are the Intended Purpose(s) of the product(s)
How long has the product been placed on your domestic market
What is the estimated retail unit price in USD
Does your company have any Branch Office or Filial in the European Union member states?* *
If yes, details thereof
Give the addresses
Have you ever sold the product(s) concerned onto the EEA market (EU+EFTA)?* *
If you answered yes, details thereof
Have you ever filed an "Incident Report" to the Competent Authorities within the EEA (EU+EFTA) *
If yes details thereof
Have you ever issued a "Product-Recall" to the products sold within the EEA (EU+EFTA) *
If yes give more details
Testing Report, Quality Certificate or Product Registration Certificate
Radio:
If yes more particulars are needed
National Standard(s) apply to your products, if any:
International Standard(s) apply to your products, if any:
European Standard(s) apply to your products, if any:
Testing Laboratory)(ies),if applicable
Have your products been sold to the US market?* *
if yes, since when
Does your company have a Liability Insurance? *
If so the required details
Any other file you want us to see
Word Verification: