CE Marking
Authorized Representative for
Clear Image Devices LLC
Medical Devices
(Service renewal needed by:
5 June 2022
)
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| Products
| CE Marking | Authorized Representative
| Manufacturer
| Importer/Distributor
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Products
(Products below have been consolidated/added since: 30 Dec 2015.)
(Products below have been added since: 8 Feb 2018.)
(Products below have been added since: 8 Nov 2018.)
Please learn more about the products at
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CE Marking
| Represented by Wellkang since: | 23 December 2013 |
| Wellkang Auth Rep Certificates no.: |
ARMDD141253A170915LNRW (Valid until: 5 Sept 2022)
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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/CA014288
(Former Ref. No.: GB/CA01/CA011234)
The change of manufacturer's address and contact details has been updated with the MHRA under MHRA ref. AC20170914004.
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 EEA/EU27/NI markets)
(excluding the market of Great Britain (GB): England, Scotland & Wales, after 1 Jan 2021)
WellKang Ltd
Enterprise Hub, NW Business Complex, 1 Beraghmore Road, Derry, BT48 8SE, Northern Ireland
(Former Registered Office: 29 Harley Street, London, W1G 9QR, England)
Tels: +44(20)32876300, +44(33)33031126 Fax: +44(20)76811874
Web: www.CE-marking.eu www.CE-marking.com www.wellkang.ltd.uk
(Wellkang's SRN in EUDAMED: XI-AR-000001836)
http://www.wellkang.ltd.uk/wellkang-brexit-notice.html
| Former Authorized Representative: |
Barclay Phelps
196 High Road
London N22 8HH
United Kingdom
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Manufacturer
Clear Image Devices LLC
5225 68th St., Suite 8
Caledonia, MI 49316,
USA
Ph: +1.616.455.7704
Fx: +1.616.871.7172
W: www.clearimagedevices.com
Email: (available but not published here)
Former address:
3930 Michael Rd. North,
Ann Arbor, MI 48103
USA
Ph: +1.734.6456459
Fx: +1.734.6610220
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Last updated on
5/Jan/2021
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