Certificate Overview:

This document is a certificate for the Quality Management System of ASPEL S.A., issued by TÜV Rheinland LGA Products GmbH. It confirms that ASPEL S.A. has established and applies a quality management system in compliance with the EN ISO 13485:2016 standard, specifically for medical devices.

Certificate Details:

• Registration No.: SX 1032460-1
• Certificate Holder: ASPEL S.A., located at os. H. Sienkiewicza 33, 32-080 Zabierzów, Poland
• Report No.: 84966851-50
• Effective Date: 2024-02-29
• Expiry Date: 2027-02-08
• Issue Date: 2024-02-29
• Replaces Certificate: SX 1032460-1 issued on 2021-02-15

Scope of Certification:

The certification covers the design and development, production, distribution, installation, and servicing of active medical devices for vital functions monitoring and related accessories.

Additional Information:

The quality management system is subject to yearly surveillance to ensure ongoing compliance with the standard. The certificate can be validated online at Certipedia.