RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 60 of 61
11 Appendices
Excerpt from the EC Declaration of Conformity in accordance with MDD
The manufacturer named below
RAUMEDIC AG
Hermann-Staudinger-Strasse 2
95233 Helmbrechts, Germany
declares under its sole responsibility that the following designated medical devices
RAUMEDIC Conformity Group No.: 0044
Name of the conformity group: RAUMED NeuroSmart
Class: IIb
are developed, produced, tested and sold in accordance with the requirements of EC directive
93/42/EEC, appendix I.
The EC conformity declaration process takes place according to appendix II, point 3 of EC di-
rective 93/42/EEC.
The declaration of EC conformity was issued for the first time in 2020.
Observance of the procedures specified in directive 93/42/EEC is subject to monitoring by the
notified body:
TÜV SÜD Product Service
Ridlerstraße 65
80339 Munich
Ref. No.: 0123
RAUMEDIC AG
0123
This document is for information only
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