EC DECLARATION OF CONFORMITY

Declaration No.: 01/2020

Manufacturer name „bawariamed“ d.o.o.

and address: Jovana Bijelića 19a, 78000 Banjaluka, BIH/RS

Name of the device: Gynecological chair medielle

Model/Type: B100

Classification: Klass I (Annex II, excluding section 4)

GMDN: 38447

This declaration of conformity is issued under the sole responsibility of „bawariamed“ d.o.o. We
hereby declare that he medical device(s) specified above meet the provision of the council directive
93/42/EEC, for medical devices. This declaration is supported by the Quality System approval to ISO
13485 issued by MSCB-103. All supporting documentation is retained at the premises of the
manufacturer.

The product was a subject of conformity assessment procedure described in Annex II Conformity
assessment route: „bawariamed“ d.o.o. uses the following procedures for the CE - labeling of
their products according the council directive 93/42/EEC:

Class I, EC conformity declaration according to Annex II, excluding section 4

Harmonized standards EN ISO 13485:2016; EN ISO 15223-1:2016;

related to the medical EN 60601-1; EN 60601-1-2; SRPS EN 60601-1-2:2016;
device:

Authorised
Representative
name and adrress:

Place and date ofissue: Banjaluka, 18.03.2020. Signature:

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Borislav Petrović