EC Declaration of Conformity
according to the Medical Devices Directive 93/42/EEC (as amended 2007/47/EC)
Respiratory Humidifier AMHH2600A
is herewith confirmed to comply with the requirements set out in the Council Directive on the harmonisation of the Laws of
the Member States concerning Medical Device Directive 93/42/EEC (as amended by 2007/47/EC) with compliance to
conformity assessment Annex II (excluding section 4) as product classification Class IIa certified by Det Norske Veritas
(Notified Body number 0434).
The following harmonised standards are applied, in respect of product manufacturing control and product performance and
safety in use:
• Medical Device Directive 93/42/EEC (as amended)
• EN 1041:2008, EN 980:2008, EN ISO14971:2009, EN ISO8185:2009, EN 60601‐1:1990 ; EN 60601‐1‐2:2007,
The undersigned hereby declares that the medical device specified above conforms to the Essential Requirements listed in
Annex II (excluding section 4) of Medical Device Directive 93/42/EEC.
European Authorized Representative:
Wellkang Tech Consulting
Suite B, 29 Harley Street London W1G 9QR, UK
The following person is responsible for the compliance of this Declaration:
Great Group Medical Co., Ltd.
No.81, Sec 1, Kuo Kuang Road, Dali City, Taichung 41262 Taiwan, R.O.C
Great Group Medical Co., Ltd (GGM) warrants that a previously unused device, when used in accordance with the instructions
for use (IFU), shall be free from defects in workmanship and manufacturing materials and will perform in accordance with
GGM’s published product specifications for a period of 2 (two) years from the date of purchase from GGM or from an
Accessories, such as temperature probes and heater wire cables are warranted for a period of 1 (one)
year from the date of purchase from GGM or from an approved stockist.
This warranty excludes:
• Accidental damage
• Misuse or abuse
• Unauthorised Modification
• Failure to adhere to IFU
• Use in unsuitable physical or
• Failure to use original or approved
• Other defects not related to
manufacturing materials or