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EU Certificate

EU Certificate
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EU Certificate

Product catalog summary
EU Certificate Overview
This document is an EU Certificate issued by DEKRA Certification GmbH, a Notified Body of the European Union, for the assessment of the quality management system of Stihler Electronic GmbH. The certification is in accordance with the Medical Device Regulation (EU) 2017/745 Annex IX Chapter I+III.

Manufacturer Details
  • Company: Stihler Electronic GmbH
  • Single Registration Number (SRN): DE-MF-000006188
  • Address: Gaussstrasse 4, 70771 Leinfelden-Echterdingen, Germany

Certificate Details
  • EU Certificate Number: 50192-60-00-00
  • Validity: From 2024-08-12 to 2028-07-23
  • Notified Body ID: 0124

Quality Management System
The certificate confirms that Stihler Electronic GmbH applies a quality management system for the medical devices listed in the annex. The certificate's validity is contingent upon successful annual surveillance audits.

Annex: Device Details
The certificate includes the following devices under Class IIa:
  • ASTOTUBE®
  • Article Numbers: M77432002, M77449004, M77449003, M77455502, M77460002
  • Basic-UDI-DI: 426011414TUBE5P
  • EMDN Code: A030201
  • MDN Code: 0102

Changes to Previous Certificate
No changes were noted from the previous certificate.
See more

Catalog excerpts

EU Certificate-1

EU Certificate for the assessment of the quality management system according to Medical Device Regulation (EU) 2017/745 Annex IX Chapter I+III As a Notified Body of the European Union DEKRA Certification GmbH certifies, that the manufacturer Stihler Electronic GmbH Single Registration Number (SRN): DE-MF-000006188 Gaussstrasse 4, 70771 Leinfelden-Echterdingen, Germany applies a quality management system according to Annex IX Chapter I+III of the Medical Device Regulation (EU) 2017/745 for the medical devices listed in the annex. This certificate is based on the assessments listed in CNo50192-00 and is only valid in conjunction with the successful completion of the annual surveillance audits. EU Certificate no.: 50192-60-00-00 Certificate valid from: Certificate valid to: Digitally signed by Markus RAINER Kopf Date: 2024-08-13 17:38:41+02:00 DEKRA Certification GmbH, Stuttgart Notified Body ID number: 0124 DEKRA Certification GmbH * Handwerkstraße 15 * D-70565 Stuttgart * www.dekra-certification.de/medizinprodukte

 Open the catalog to page 1
EU Certificate-2

Annex to the EU Certificate no. 50192-60-00-00 Following devices/device categories are included in this certificate: Change(s) to previous certificate: n.a. DEKRA Certification GmbH * HandwerkstraGe 15 * D-70565 Stuttgart * www.dekra-certification.de/medizinprodukte

 Open the catalog to page 2

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.