RAUMED NeuroSmart Instruction Manual
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany
zwo-541EN Rev 3 / 2022-05-03
Page 61 of 61
Excerpt from the EC Declaration of Conformity in accordance with AIMDD
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.: 0039
Name of the conformity group: Transdermal telemetry system readP
Class: AIMD
are developed, produced, tested and sold in accordance with the requirements of EC directive
90/385/EEC, appendix 1.
The EC conformity declaration process takes place in accordance with appendix 2 of EC Directive
90/385/EEC.
The first declaration of EC conformity was issued for the first time in 2009.
Observance of the procedures specified in directive 90/385/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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