RAUMEDIC MPR1 - Extract from the EU Declaration of Conformity according to AIMDD

Instructions for Use MPR1 DATALOGGER
Manufacturer: zwo-399EN
RAUMEDIC AG, Hermann-Staudinger-Strasse 2, 95233 Helmbrechts, Germany Rev. 9, 2020-10-16
Page 98 of 98
Extract from the EU Declaration of Conformity according to AIMDD
The manufacturer hereinafter mentioned
RAUMEDIC AG
Hermann-Staudinger-Strasse 2
95233 Helmbrechts
declares under its sole responsibility that the following designated medical products
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 according to appendix 2 of EC directive
90/385/EEC.
First declaration of CE-conformity: 2009
Adherence to the processes specified in directive 90/385/EEC is covered through the monitoring
by the "notified body":
TÜV SÜD Product Service
Ridlerstrasse 65
80339 München
Identification No.: 0123
RAUMEDIC AG
0123
This document is for information only