FAN LactoFAN2, Instructions For Use Manual

Page: 29 / 30

Manual LactoFAN 2 29 of 30
Declaration of Quality
The Fischer ANalysen Instrumente GmbH (FAN GmbH) hereby certifies
that the H
2
–
-breath test analyzer
LactoFAN 2
Device No.:

has been produced and tested according to the valid guidelines of our company

has passed without objections all performance check procedures during the
manufacturing process and the final check according to the valid test specifications

meets all specifications of its valid technical documentation.
The CE marking has been affixed.
Authorized signed:
Leipzig,
(Place, date)
(Name)
The breath test analyzer LactoFAN2 of the FAN GmbH is a Medical Device Class Im in the scope of the valid
European laws regarding medical devices:

The Act on Medical Devices (Medical Devices Act) (Medizinproduktegesetz - MPG) of 7th August 2002
(Federal Law Gazette I, p. 3146)

The Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive
- MDD)
The Quality Management (QM) of Fischer ANalysen Instrument GmbH is certified according to DIN EN ISO
13485:2003 + AC:2009 and DIN EN ISO 9001:2008. The QM has successfully undergone a conformity
assessment procedure according to MDD, annex II (without section 4), by the TÜV Rheinland LGA Products
GmbH.
According to the MDD, article 11, the FAN GmbH is therefore entitled to affix the CE conformity marking on
their H2-breath test analyzers LactoFAN2.