1. Catalogs
  2. Labtech
  3. DIN EN ISO 13485:2021 EN ISO 13485:2016 / A11:2021 ISO 13485:2016

DIN EN ISO 13485:2021 EN ISO 13485:2016 / A11:2021 ISO 13485:2016

DIN EN ISO 13485:2021 EN ISO 13485:2016 / A11:2021 ISO 13485:2016

Product catalog summary
Certificate Overview
This document certifies that Labtech Kft, located at Vág u. 4, 4031 Debrecen, Hungary, has implemented and maintains a Quality Management System.
Scope of Certification
The certification covers the design, manufacture, distribution, and service of medical devices and systems for non-invasive cardiology diagnostics.
Standards Fulfilled
The management system of Labtech Kft fulfills the requirements of the following standards:
  • DIN EN ISO 13485:2021
  • EN ISO 13485:2016 / A11:2021
  • ISO 13485:2016
Certification Details
  • Certificate Registration No.: 31623209 MP2021
  • Certificate Unique ID: 1000225474
  • Effective Date: 2025-05-11
  • Expiry Date: 2028-05-10
Certification Body
The audit was performed by DQS Medizinprodukte GmbH, and the certificate was issued in Frankfurt am Main.
See more

Catalog excerpts

DIN EN ISO 13485:2021 EN ISO 13485:2016 / A11:2021 ISO 13485:2016-1

CERTIFICATE This is to certify that the company Labtech Kft Vág u. 4 4031 Debrecen Hungary has implemented and maintains a Quality Management System. Scope: Design, manufacture, distribution and service of medical devices and medical devices systems for non-invasive cardiology diagnostics. Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was verified that the management system fulfills the requirements of the following standard: Effective date Expiry date Heinrich von Mettenheim Managing Director August-Schanz-Straße 21, 60433 Frankfurt am Main, Tel. +49 (0) 69 95427-300, [email protected] The validity of the certification can only be verified by the QR-code.

 Open the catalog to page 1

All Labtech catalogs and technical brochures

*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.