CERTIFICATE

CERTIFICATE

Product catalog summary
Certification Overview: This document is a certification issued by the Certification Body of TÜV Hessen, confirming the introduction and maintenance of a management system for Lemon Medical GmbH. The certification is regularly monitored and its validity can be verified online.
Scope: The certification covers the development, production, and distribution of accessories for cardiopulmonary function diagnostic devices, as well as the distribution, service, and installation of medical devices for cardiopulmonary function diagnostics within the European Economic Area (EEA).
Standards: The management system complies with EN ISO 13485:2016/AC:2018 and EN ISO 13485:2016/A11:2021 standards.
Certificate Details:
  • Certificate Registration No.: 73 105 5336
  • Certificate Validity: From 2024-05-23 to 2027-04-29
  • Previous Certificate Valid Until: 2024-04-29
Issuer Information: TÜV Technische Überwachung Hessen GmbH, located at Robert-Bosch-Strasse 16, 64293 Darmstadt, Germany.
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Catalog excerpts

CERTIFICATE-1

EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/ 13485:2016/A11:2021 A11:2021 Evidence of conformity has been furnished. Certificate registration No.: 73 105 5336 Certificate valid from: 2024-05-23 to: 2027-04-29 previous certificate was valid until: 2024-04-29 Lemon Medical GmbH Dr.-Georg-Schaefer-Str. 14 97762 Hammelburg / Germany Scope - for the European Economic Area: Development, production and distribution of accessories for cardiopulmonary function diagnostic devices as well as distribution, service and installation of medical devices for cardiopulmonary function diagnostics in the EEA Page 1 of 1 This certification confirms the introduction and maintenance of the Management system specified above and is monitored regularly. The current validity is verifiable at www.proficert.de. Original certificates contain a glued hologram. TÜV Technische Überwachung Hessen GmbH, Robert-Bosch-Strasse 16, 64293 Darmstadt, Germany Phone +49 6151/600331 Rev-GB-2401 Translation of German original Dr. M. Ponick Head of Certification body Release: Darmstadt 2024-05-23 Certification Body of TÜV Hessen

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