Our Quality Management
Quality as the foundation for safe and high-performance products
Quality Management of Geuder AG
As a manufacturer of ophthalmic surgical products, Geuder AG operates a quality management system in accordance with the following guidelines:
System Certificate
ISO 13485: 2016
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CE Certificates
Regulatory Letter for MDR 742901
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Notified Body Confirmation Letter Geuder AG
Notified Body Confirmation Letter Geuder AG
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Change of notified body: At the beginning of 2019, Geuder AG switched from BSI Group UK to the notified body BSI Group The Netherlands B.V. with the identification number 2797. This change is related to Brexit.
Products already placed on the market bearing the marking CE 0086 or CE 0535, the numbers of Geuder AG’s previous notified bodies, remain marketable until the expiry of their usability.
Quality Management of Fluoron GmbH
As a manufacturer of medical devices, Fluoron GmbH operates a quality management system in accordance with the following guidelines:
System Certificate
ISO 13485: 2016 and EN ISO 13485: 2016
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CE Certificate
Notified Body Confirmation Letter Fluoron
Notified Body Confirmation Letter Fluoron GmbH
Download certificate →
Change of notified body: At the beginning of 2019, Fluoron GmbH switched from BSI Group UK to the notified body BSI Group The Netherlands B.V. with the identification number 2797. This change is related to Brexit.
Products already placed on the market bearing the marking CE 0086 or CE 0535, the numbers of Fluoron GmbH’s previous notified body, remain marketable until the expiry of their usability.