CE Marking
  Authorized Representative for  
  Halosense Inc 
Medical Devices

 (Service renewal needed by: 10 Dec 2020) 

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CE Marking

Represented by Wellkang since: 25 Jan 2016
Wellkang Auth Rep Certificates no.: ARMDD161384A191128LNY5 (Valid until: 24 Jan 2021)
ARMDD161384A181116LNY4 (Valid until: 24 Jan 2020)
ARMDD161384A171124LNY3 (Valid until: 24 Jan 2019)
ARMDD161384A161024LNY2 (Valid until: 24 Jan 2018)
ARMDD161384A160127LN (Valid until: 24 Jan 2017)
Notified Body:NOT applicable
(for class I MD non-sterile, without measuring function)
Product Classification:Class I Medical Devices, non-sterile, without measuring function
(under MDD Directive 93/42/eec)
Conformity Modules: Module A
EC Declaration of Conformity (Annex VII) + Technical File
Lead Competent Authority:UK Medicines & Healthcare Products Regulatory Agency
Class I Device Registration
(Per Article 14, Directive 93/42/eec.)
Ref. No.: GB/CA01/CA016621

Click here to verify online at the website of the MHRA.

Click here to view the registration certificate.



Authorized Representative
in the European Economic Area (incl. European Union and EFTA member states):

WellKang Ltd
16 Castle Street, Dover, CT16 1PW, England
29 Harley Street, London, W1G 9QR, England
The Enterprise Hub, North West Business Complex,
1 Beraghmore Rd. Derry, BT48 8SE, N. Ireland
Tels: +44(20)32876300 & +44(33)33031126     Fax: +44(20)76811874
Web: www.CE-marking.eu   www.CE-marking.com    www.wellkang.ltd.uk



Manufacturer

Halosense Inc
48 Knights Bridge,
London, Ontario N6K3R4,
Canada
Ph: +1-519-641-7258
Fx: +1-519-641-7258
W: www.salinetherapy.com
Email: (available but not published here)



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Last updated on 28 Nov 2019.