Ec Declaration Of Conformity - Hettich HettCube 200 Manual De Instrucciones

Andreas Hettich GmbH & Co. KG • Föhrenstraße 12 • D-78532 Tuttlingen • Germany
We hereby declare under our sole responsibility that the designated device and its accessories, which are listed in
the technical documentation for this device and whose conformity has been assessed together with the device,
conform to the Directive 98/79/EC on in vitro diagnostic medical devices.
Type of device:
Incubator / cooling incubator
Type designation:
HettCube 200 / 200 R, HettCube 400 / 400 R, HettCube 600 / 600 R
The conformity evaluation process was performed in accordance with appendix III of Directive 98/79/EC.
The following additional European directives and ordinances have been applied:
EMC Directive 2014/30/EU
•
RoHS II Directive 2011/65/EU (without participation of a notified body)
•
Ordinance (EC) No. 1907/2006 (REACH) (without involvement of a notified body)
•
Ordinance (EC) No. 2012/19/EU (WEEE)
•
Applied standards:
According to the list of applied standards, which is part of the product file.
Tuttlingen, 2019-09-09
Klaus-Günter Eberle
Managing Director

EC Declaration of conformity

of the manufacturer