RAUMEDIC MPR1 - Enclosures; Extract from the EU Declaration of Conformity according to MDD

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 97 of 98
15 Enclosures
Extract from the EU Declaration of Conformity according to MDD
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.: 0034
Designation of the Conformity Group: RAUMEDIC MPR 1 DATALOGGER
Class: IIb
are developed, produced, tested and sold in accordance with the requirements of EC directive
93/42/EEC, Appendix I.
The EU Conformity Evaluation Procedure was carried out in compliance with Annex II, point 3 of
the EU Directive 93/42/EEC.
First declaration of CE-conformity: 2004
The observation of the process defined in Directive 93/42/EEC is subject to monitoring by the
“notified body”:
TÜV SÜD Product Service
Ridlerstrasse 65
80339 München
Germany
Identification No.: 0123
RAUMEDIC AG
0123
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