IS013485 Certificate EN

IS013485 Certificate EN

Product catalog summary

Certification Overview:

The document is a certification issued by SLG Prüf- und Zertifizierungs GmbH to Von Ardenne Institut für Angewandte Medizinische Forschung GmbH, located in Dresden, Germany. The certification confirms the implementation and use of a quality management system by the company.

Scope of Certification:

  • Manufacture, production, maintenance, and distribution of whole-body hyperthermia systems.
  • Maintenance and trading of oxygen concentrators and accessories.

Standards and Validity:

  • The certification is in accordance with DIN EN ISO 13485:2021-12 (ISO 13485:2016), which pertains to quality management systems for medical devices.
  • The certificate is valid from April 16, 2024, until August 28, 2025.

Contact Information:

SLG Prüf- und Zertifizierungs GmbH is located in Hartmannsdorf, Germany. They can be contacted via phone at +49 3722 7323-0 or email at [email protected].

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Catalog excerpts

IS013485 Certificate EN-1

Certificate Company: Von Ardenne Institut für Angewandte Medizinische Forschung GmbH Zeppelinstraße 7 01324 Dresden, Germany Certificate number: Audit report: Valid from: Valid until: SLG Prüf- und Zertifizierungs GmbH certifies that the above mentioned company has implemented and uses a quality management system covering the scope of Manufacture, production, maintenance and distribution of wholebody hyperthermia systems as well as maintenance and trading of oxygen concentrators and accessories in accordance with the requirements of D. Eisentraut Certification Body SLG Prüf- und Zertifizierungs GmbH Burgstädter Straße 20 09232 Hartmannsdorf · Germany

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