Publicidad
14. Declaración de conformidad de la CE
Company: Enbio Technology Sp. z o. o., ul. Sportowa 8 C, 81-300 Gdynia, Poland
declares with sole responsibility, that medical devices: STEAM STERILIZERS, models:
• Enbio S
• Enbio PRO
• Enbio XS
complies with provisions of Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices (as amended). The device has been classified in Class IIb in accordance with rule 15 of
Annex IX of the above mentioned Directive.
Conformity assessment has been carried out in accordance with Annex II without point 4 of the
above Regulations.
The conformity assessment has been conducted by the Notified Body No. 2274
TUV Nord Polska Sp. z o.o.
Mickiewicza 29 Street
40-085 Katowice
Poland
Gdynia
14.01.2021
Version: 05_01.2021
56
EC Declaration of Conformity
Marek Krajczyński
President of the Board
Sebastian Magrian
Member of the Board
Publicidad
