Appendix G: Manufacturer's Declarations Of Conformity - NeuroMetrix NC-stat DPNCheck User Manual

Appendix G: MANUFACTURER'S DECLARATIONS OF CONFORMITY
(in accordance with ISO/IEC 17050-1 and ZLG 3.9 A 4)
MANUFACTURER
NeuroMetrix, Inc
4- B Gill Street
Woburn, MA 01801 USA
Object of the declaration: NC-stat DPNCheck Nerve Conduction Velocity Measurement System
Catalog Number:
Under the sole responsibility of NeuroMetrix, Inc., the object(s) of the declaration described above is in
conformity with the requirements of the following documents:
Medical Device Directive 93/42/EEC:
Annex II – NC-030, Class IIa, rule 10
Annex VII – NC-DP1, NC-DP2, Class I, rule 1
European Authorized Representative:
EMERGO Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Notified Body (Annex II Products Only):
TüV SüD Product Service GmbH
Notified Body Number 0123
Zertifizierstelle
Ridlerstasse 65
80339 Munchen Germany
Date of First CE Marking: September 1, 2011 (NC-030, NC-DP1), September 11, 2012 (NC-DP2)
Validity: Until expiration of
Signed for and on behalf of NeuroMetrix, Inc.
Rainer Maas
Director of QA/RA/Compliance
Woburn, MA 01801 USA
NC-030 (Device), NC-DP1 (Biosensor), NC-DP2 (Biosensor)
CE Certificate Number G1 16 10 40014 014
September 16, 2019
©2021 NeuroMetrix, Inc. All Rights Reserved. PN2203282 Rev N
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NC-stat DPNCheck Device User Manual