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.
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.
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.
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..
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.