Quality Management
at Geuder

As a manufacturer of ophthalmic surgical products, Geuder AG maintains a quality management system in accordance with the following guidelines:

System Certificates

Geuder AG

ISO 9001: 2015

Geuder AG

ISO 13485: 2016

CE-Certificates

Geuder AG

Geuder Annex II MDD
CE575415

Geuder AG

Geuder Annex II MDD
CE711663
Megatron Systems

Geuder AG

Geuder Annex II MDD
CE 711664
Endotron Systems

Geuder AG

Geuder Annex II MDD
CE 711665
Diathermy Instruments

Geuder AG

Geuder Annex V MDD
CE 575413

Geuder AG

Geuder MDR 742901

Notified Body Confirmation Letter Geuder AG

Change of Notified Body

Beginning of 2019, GEUDER AG has changed its Notified Body from BSI Group UK to BSI Group The Netherlands B.V. (identification number 2797) in conjunction with the Brexit. The identification numbers of the previous Notified Bodies CE 0086 and CE 0535 remain valid for the products we have hitherto first placed on the market, until their shelf life has expired.

Quality Management
at Fluoron
As a manufacturer of medical devices, Fluoron GmbH maintains a quality management system in accordance with the following guidelines:

CE-Certificate

Geuder AG

Fluoron Annex II
(excluding Section 4) MDD

Notified Body Confirmation Letter Fluoron

System Certificate

Geuder AG

ISO 13485: 2016 und
EN ISO 13485: 2016

Change of Notified Body

Beginning of 2019, Fluoron GmbH has changed its Notified Body from BSI Group UK to BSI Group The Netherlands B.V. (identification number 2797) in conjunction with the Brexit.

The identification numbers of the previous Notified Bodies CE 0086 and CE 0535 remain valid for the products we have hitherto first place on the market, until their shelf life has expired.