Instructions for Use RAUMEDIC
MPR2 logO
Manufacturer: zwo-400EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9 2020-09-22
Page 99 of 99
15 Enclosures
Extract from the EU Declaration of Conformity
The manufacturer hereinafter mentioned
RAUMEDIC AG
Hermann-Staudinger-Strasse 2
95233 Helmbrechts
Germany
declares under its sole responsibility that the following designated medical products
RAUMEDIC conformity group no.: 0038
Name of the conformity group: RAUMEDIC MPR2 logO DATALOGGER
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
directive 93/42/EEC.
The first declaration of EC conformance occurred on 28.10.05.
Adherence to the processes specified in directive 93/42/EEC is covered through the
monitoring by the "notified body":
TÜV SÜD Product Service
Ridlerstrasse 65
80339 München
Germany
Identification No.: 0123
RAUMEDIC AG
This document is for information only
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