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Sterile dressing materials from SÖHNGEN® have a shelf life of 20 years from the date of manufacture, provided the sterile packaging is undamaged and stored properly. Relevant literature and standards works summarize the state of the art as follows: the loss of sterility is considered to be event-related and not time-related - that is, specifically: due to opening or damage to the packaging. Therefore, sterile products require careful handling and storage. First aid containers from SÖHNGEN® are exemplary in this respect. Common wound plasters do not come under the heading of sterile dressing materials. The usability here, especially with regard to adhesive strength, depends on the storage temperature. The adhesive strength of the plasters should be checked regularly.

With validity from 26.05.2021 we confirm for the medical devices manufactured by us Class I medical devices manufactured by us

• The products comply with the requirements of the MDR
• An EU declaration of conformity has been drawn up as part of the conformity assessment procedure to be applied in accordance with MDR
• The products are provided with the CE marking
• The devices are accompanied by the safe use information
• The devices have been assigned a basic UDI-DI

Class Is medical devices

• For these devices a valid MDD certificate from our Notified Body, BSI NL (2797), valid until 26.05.2024, is available
• Within the framework of the conformity assessment procedure to be applied according to MDD, an EU declaration of conformity was drawn up before the MDR came into force.
• The products are marked with the CE marking and the identification number of our Notified Body, 2797 = BSI NL.
• The products are accompanied by the information for safe use
• The devices continue to comply with the requirements of the MDD
• The requirements of the MDR with regard to post-market surveillance, market surveillance, vigilance and registration of economic operators and products are fulfilled.

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You can find tables of contents of our products in the download area under "Tables of contents".