CE Marking (CE Mark) Inquiry at www.CE-marking.com

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Questionnaire for
CE Marking, Auth Rep (EC Rep) & UK Responsible Person
Wellkang do NOT offer consultation by telephone.
Please submit your inquiry using the form below.
(Attention for INCIDENT Reporting)

In Chinese

Wellkang is a registered EU Authorised Representative (EC Rep) in the European Commission's EU medical device database EUDAMED under a unique Single Registration Number (SRN): XI-AR-000001836 for the markets of EEA/EU27 & Northern Ireland.

Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market of Great Britain: England, Wales & Scotland, after 1 Jan 2021, which is no longer part of the EU single market after Brexit.

Are you ready for Brexit? Do you have a Brexit contingency plan?

You may need either an EU/EC European authorized representative based in EU-27 countries or a UK authorised representative based in UK, or may even need both EU & UK representatives (UK Responsible Person), depending on different brexit scenarios.

Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading
consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland).

Wellkang team can help you under all Brexit scenarios!

Our Anti-SPAM Policy:
Wellkang have a strict Anti-SPAM policy and Wellkang never send out un-solicited SPAM messages!
To contact Wellkang via Internet, please always use our online feedback or inquiry forms. Do not send un-solicited email to Wellkang, any un-solicited (including spam) emails will be deleted automatically and may never reach us. Our system blocks and deletes automatically, without notice to the sender, emails originated from known IP numbers and email addresses which have/had been used to send SPAM or junk emails. Wellkang can therefore not guarantee the receipt of any emails sent to us without using one of the online feedback or inquiry forms placed at any of Wellkang´s websites.

Ordering, Post-Sales Service, Repairing, Warranty, Claims, etc:
Wellkang is NOT involved in anyway in either the Design/Manufacture/Test or Marketing/Distribution/Sales/Supply/Installation of any CE-marked product, for which Wellkang is the regulatory Authorised Representative (EC Rep) according to the Label, Package or Instruction For Use (IFU), therefore ALL matters regarding Placing an Order, Post-Sales Service, Repairing, Warranty, Claims, etc. should be addressed directly to either the Manufacturer or the Importer/Distributor according to the Label, Package or IFU, or the Supplier who has sold/supplied you with the product. A regulatory Authorised Representative (EC Rep) is NOT a commerical Sales Representative.

Verification:
In order to fight against counterfeiting, and prevent fraud and forgery, Wellkang answers only inquiries submitted by using our online forms, we do NOT disclose our clients' information over phone. If you are importing/distributing/dealing with our clients (or a company who claims to be our client) and you want to verify whether or not Wellkang is the European Authorised Representative for a non-EU manufacturer, you must ask our client (the non-EU manufacturer) to introduce you to us, otherwise we may be unable to answer your verification of our clients' information. Futheremore, only buy medical devices from a legitimate manufacturer or supplier, if you are buying any CE-marked products online, such as via E-bay or Amazon, please always make sure that the seller is based within the EEA countries and the seller is either the genuine EEA manufacturer or a distributor/dealer authorised by the genuine EEA or non-EEA manufacturer, in accordance with the labelling. Please verify with the genuine manufacturer whether any online seller is authorised and make sure the product is aimed for the market where the buyer is located.
Further reading:
MHRA Medical safety alert: Counterfeit or non-CE marked dental medical devices..
MHRA Press release: People warned about buying fake dental equipment online.
MHRA Press release: Fake and unapproved dental curing lights sold online - MHRA warns dentists..

INCIDENT Reporting:
If you want to inform us about any INCIDENT caused by a CE-marked product, for which Wellkang is the Authorised Representative (EC Rep) according to the Label, Package or Instruction For Use (IFU), please send us a fax immediately at no. +44(20)7681-1874 and provide us with at least the following information:
Product Name; Batch/LOT/Serial No.; Name of Manufacturer; Name of Importer or Distributor on the Label (if available); Description of the INCIDENT: Date, Place, What has happened, etc.

Warning & Alert:
We have become aware that there have been a number of cases where some companies are using falsified either CE marking certificates, EC Declaration of Conformity, or Labelling on which Wellkang is listed as the European Authorised Representative (EC Rep). Please be advised that, Wellkang has NEVER issued ANY Certificate of Conformity or EC Certificate for CE Marking to ANY companies. For further details, please refer Wellkang's Warning & Notice.

CCC Mark Inquiry:
If you are inquiring about CCC-China Compulsory Certification Mark for (a) specific product(s), please use our CCC Mark online inquiry form at http://www.CCC-mark.com and submit your inquiry online with the detail information about the product(s) concerned. Please be advised that Wellkang answer only inquiries submitted by using our online forms.

CE Marking Inquiry:

If your question is WHETHER OR NOT your product will NEED CE marking and/or WHICH EU Directive may apply to your product(s), please click here and you will most probably find the answer yourself.

If your question is about standard(s), for instance, WHICH European and/or international standard(s) may apply to your product(s), please click here and find the answers.

If your question is about Notified Bodies and/or Testing Labs, for instance, WHETHER a Testing Lab is a Notified Body or WHETHER a Notified Body is authorized to issue certification(s) for specific directive(s)/product(s), please click here and find the answers.

Wellkang do not give free consultation over telephone. If you are inquiring about matters other than those mentioned above, please fill out following form and click on SUBMIT button (at the end of this form) to send your inquiry to Wellkang. The MORE accurate information about your product(s) you provide us with, the MORE we can assist you. All fields marked with * are required.

How did you find Wellkang?*

Your Inquiry Is About*:

Your Title*:

Your Position*:

Your Name*:

Company Name*:

(Your Company) Website*:

Your E-Mail*:

Repeat (re-type) your E-Mail*:

* Wellkang give priorities to feedback/inquiry from a
creditable email address (such as: something@CompanyWebsite.com, etc.)

with preferably an established website. If you use a free email account such as xxx@gmail.com, xxx@yahoo.com, your free email address must be shown on your website for verification.

Alternative Email:

Address*:

City/Town*:

Province/State*:

Zip/PostCode*:

Country/Region*:

Phone Number (CountryCode-AreaCode-Number)*:

Mobile (Cell) Phone No. (CountryCode-AreaCode-Number):

Fax Number (CountryCode-AreaCode-Number)*:

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 ?*	1- Yes; 2- No; 3- Do not know If MD, which class? Class I ? Class IIa ? Class IIb ? Class III ? Do not know
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 ?*	1- Yes; 2- No; 3- Do not know If IVD, which category? Other ? Self-Testing ? List B ? List A ? Do not know
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 ?*	1- Yes; 2- No; 3- Do not know
Is your product a Personal Protective Equipment (PPE) under - Directive 89/686/EEC? 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 ?*	1- Yes; 2- No; 3- Do not know
Is your product a LVD? 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.) ?*	1- Yes; 2- No; 3- Do not know
Is your product a machinery?* 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.	1- Yes; 2- No; 3- Do not know
Is your product a Radio Equipment or Telecommunications Terminal Equipment ?* 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 radiocommunication. 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).	1- Yes; 2- No; 3- Do not know
Is your product designed or intended, whether or not exclusively, for use in play by children under 14 years of age. ?*	1- Yes; 2- No; 3- Do not know

In which year your business was founded?*

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 Wellkang?*

(Use ENTER key to break lines)

If applicable, have you chosen a Notified Body for CE-marking?*
If YES, give the name and office location
(Use ENTER key to break lines)

Have you already achieved the CE marking for the product(s) concerned through other channels than Wellkang?*
If the answer is YES, give the details.
Which Year?
(Use ENTER key to break lines)

Did (Do) you have an Authorized Representative for CE Marking in the EU?*
If YES and applicable,
1- What is/are the reason(s) you want to change your Authorized Representative?
(e.g. inadequate knowledge in EU regulatory affairs, poor service, price too high, less-known brand name, etc.)

2- Do you wish Wellkang to contact directly the Auth Rep for transferring the previous/current Technical Files for CE Marking?

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 detail.

URLs-Webpages*:
where there is info about your product & models

Please describe your products briefly:*
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?
(Use ENTER key to break lines)

Does your company have any Branch Office or Filial in the European Union member states?*
If the answer is YES, give the names of the countries where your branch/filial is/are located.

Which European Union member states are your immediately targeted markets?*
Give the name(s) of the country(ies).

Have you ever sold the product(s) concerned onto the EEA market (EU+EFTA)?*
If YES, since when? to which country(ies)?
(Use ENTER key to break lines)

Have you ever filed an "Incident Report" to the Competent Authorities within the EEA (EU+EFTA)?*
If YES, please give details.
(Use ENTER key to break lines)

Have you ever issued a "Product-Recall" to the products sold within the EEA (EU+EFTA)?*
If YES, please give details.
(Use ENTER key to break lines)

Testing Report(s), Quality Certificate(s) or Product Registration Certificate(s) obtained,
When? and Validity? if applicable:
Have you obtained any certification issued by a European Notified Body?*
If YES, please provide the certification number here and fax the copy to Wellkang at no.
+44(20)7681-1874
(Use ENTER key to break lines)

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 Laborator(y)(ies),
if applicable:

Have your products been sold to the US market?*
If YES, since when?
(Use ENTER key to break lines)

Does your company have a Liability Insurance?
If the answer is YES, give the insurance company's name.

	Customers from rest of the world, please contact Wellkang offices in: (Dover, Derry, Dublin, Ashbourne.) England (UK) & Ireland (EU-27) Ph 1: +44(20)32876300 (except holidays) Ph 2: +44(33)33031126 (except holidays) Ph 3: +353(1)2542900 (except holidays) Phone hours: Mon-Fri 09:30-15:30 GMT	Customers from China, please contact directly Wellkang Consulting (China) Rm 915, 9/F, R&D Complex Building Tsinghua Hi-Tech Park High-Tech Industrial Park (North), Nanshan District Shenzhen, Guangdong 518057, China PR Ph: +86(755)26676827 & Fax: +86(755)26676927 Phone hours: Mon-Fri 09:30-16:30 Beijing Time.