CE Marking
Authorized Representative for
Halosense Inc
Medical Devices
(Service renewal needed by:
10 Dec 2020)
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| Products
| CE Marking | Authorized Representative
| Manufacturer
| Importer/Distributor
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Products
Please learn more about the products at
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CE Marking
| Represented by Wellkang since: |
25 Jan 2016
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| 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)
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| 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
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| 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.
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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
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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.
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