As a manufacturer of medicinal products, Fluoron GmbH maintains a quality system according to the following guidelines:

DIN EN ISO 13485:

Certificate (723kB)


Certificate (490kB)

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 placed on the market, until their shelf life has expired.


Climate protection

Sustainability is an integral part of Fluoron GmbH’s activities. In our supply technology, a river-water cooling system combined with a heat recovery optimises energy demand sustainably.
As part of a promotion by the Federal Ministry for Environment, Nature Conservation, Building and Nuclear Safety’s (BMUB) Environmental Innovation Programme, Fluoron GmbH was also able to buy two new water- and energy-efficient steam sterilisers. Before we bought these new autoclaves, the hot chamber of the existing steam steriliser was cooled by cold mains water during the sterilisation process. The waste heat generated was thus lost for further use. The new energy-efficient sterilisers, on the other hand, are fitted with cooling systems that are interconnected via heat exchangers. These heat exchangers are additionally connected to Fluoron GmbH’s heat recovery system. This makes it possible to feed the waste heat recovered from cooling the steam sterilisers into the plant’s heating network. This process enables ca. 80% of the heat generated by the autoclaves to be recovered. In this way, Fluoron GmbH can save 5.0 MWh of district heating and 3.3 MWh of electricity annually. This corresponds to saving ca. 3 tonnes of CO2 per year.

Source: „Umwelt“ magazine, November 2014, by the Federal Ministry for Environment, Nature Conservation, Building and Nuclear Safety. Brochure „Energy efficiency in companies – successful examples from Baden-Württemberg“, May 2014, by the Ministry of Environment, Climate, and Energy.

Waste separation

Waste is sorted according to type and disposed of appropriately throughout the whole business.

Green electricity

Fluoron purchases and consumes regionally generated green electricity only.