Mask FesanoCare according to European standard now available
Salzweg, November 24, 2020 – The Fetter and Spiritini Group today announced the successful CE
certification of its new medical face mask. The Type IIR mask complies with the DIN EN 14683:2019
standard and is therefore suitable for use by medical professionals.
The experienced service provider from Salzweg attaches great importance to “Quality Made in
Germany” – not only is the mask produced in Germany, but the materials are also purchased from
German suppliers. “We are aware of our responsibility to bring a medical device to the market. Product
quality and, of course, the safety of people is our main focus”, said Frank Gollwitzer, Managing Director of F+S Produktion und Service GmbH, the producer of the masks. A hall at the Salzweg location was newly equipped and air-conditioned for the production while a highly automated production line
guarantees consistent quality. 60,000 masks can be produced here daily.
During the development, industrialization, testing and CE-certification, F+S was advised by Activoris
Medizintechnik, which consulted through the entire process. Over a period of six months,
requirements were documented, risks analyzed, equipment qualified, in order to create the technical
documentation for a medical device. Finally, the green light was recently given by the Hohenstein
Institute, a renowned laboratory for tests in accordance with the DIN EN 14683:2919 Type IIR standard.
“We congratulate F+S on the market launch of their first medical device,” said Axel Fischer, CEO of
Activoris Medizintechnik GmbH. “Furthermore, we are pleased that F+S is not only looking for shortterm success, but also sees mask manufacturing as a strategic market opportunity and consequently is
expanding its quality management system. However, we hope and expect that this will also be
increasingly recognized by politicians and public procurement agencies,” said the Gemünden-based
medtech specialist.
The medical masks are available immediately. F+S has already been selling a community mask under
the umbrella brand “Fesano” for several weeks. It can be ordered under www.fesanocare.de or simply
under bestellung@fesanocare.de. Each Friday from 9:00 to 12:00, the masks can be acquired also at
the factory outlet in the forest road 53 in salt way.
About FesanoCare
FesanoCare is a brand of Fetter + Spiritini Betriebshygiene & Gastro-Service
GmbH. The store sells not only FesanoCare, but also other products from
various manufacturers.
About Fetter + Spiritini Betriebshygiene & Gastro-Service GmbH
Fetter + Spiritini Betriebshygiene & Gastro-Service GmbH is your partner for occupational safety,
cleaning, paper, dispensing systems and much more. Over the years, we have continuously expanded
our product range in a customer-oriented manner, for example by offering an all-round service in the
barista area, by planning and selling individual advertising material and by constantly expanding our
medical sector. Through close cooperation with our suppliers, we can offer you products that meet the
latest technical progress and the highest standards of hygiene.
Contact us: Fetter + Spiritini Produktion & Service GmbH
Frank Gollwitzer
Phone +49 (0) 851 94959-52
frank.gollwitzer@fsgruppe.com
About Activoris Medizintechnik GmbH
Activoris is the German medical device specialist, building up on decades of management experience in
the medtech and pharma industry. Activoris supports its clients with contract manufacturing, device
developments, regulatory and business consulting as well as administration support.
Contact us: Activoris Medizintechnik GmbH
Axel Fischer
Wohraer Str. 37
35285 Gemünden, Germany
Phone +49 (0) 6691.97990.0
fax +49 (0) 6691.97990.25
axel.fischer@activoris.com
