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Certificat ISO 13485

Certificat ISO 13485

Product catalog summary

Certification Overview: mdc medical device certification GmbH has certified EVE Ernst Vetter GmbH, located at Neureutstraße 6, 75210 Keltern, Germany, for their quality management system in the development, production, and sales of rotary polishing instruments and accessories for the dental sector.

Quality Management System: The certification confirms that EVE Ernst Vetter GmbH has implemented a quality management system that complies with the EN ISO 13485 standard, specifically the versions EN ISO 13485:2016 + AC:2018 + A11:2021 - ISO 13485:2016. This standard outlines the requirements for quality management systems for regulatory purposes in the medical device industry.

Certification Validity: The certification is valid from November 22, 2023, until November 21, 2026. The registration number for this certification is D1319500014, and the report number is P22-00910-238692.

Contact Information: mdc medical device certification GmbH is located at Kriegerstraße 6, D-70191 Stuttgart, Germany. They can be contacted via phone at +49-(0)711-253597-0 or fax at +49-(0)711-253597-10. More information can be found on their website at http://www.mdc-ce.de.

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Catalog excerpts

Certificat ISO 13485-1

mdc medical device certification GmbH certifies that EVE Ernst Vetter GmbH Neureutstraße 6 75210 Keltern Germany for the scope development, production and sales of rotary polishing instruments and accessories for the dental sector has introduced and applies a Quality Management System The mdc audit has proven that this quality management system meets all requirements of the following standard EN ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes EN ISO 13485:2016 + AC:2018 + A11:2021 - ISO 13485:2016 Valid from Valid until Registration no. Report no. Stuttgart Head of Certification Body mdc medical device certification GmbH Kriegerstraße 6 D-70191 Stuttgart, Germany Phone: +49-(0)711-253597-0 Fax: +49-(0)711-253597-10 Internet: http://www.mdc-ce.de

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