DECLARATION OF CONFORMITY

We, AngelBiss Medical Technology Co., Ltd, as the Product Owner, hereby declare that the
below mentioned devices have been classified according to the classification rules and conform
to the Essential Principles for Safety and Performance as laid out in the Medical Device
Regulations in Thailand according to the Medical Device Act B.E. 2551 (2008) and the amended
Medical Device Act B.E. 2562 (2019), 2nd edition.

Name and Address of Product Owner:

ANGELBISS MEDICAL TECHNOLOGY CO., LTD
R2, NO.106, SHUANGHE ROAD, DIANSHANHU TOWN, KUNSHAN, 215345 JIANGSU, CHINA

Name and Address of Physical Manufacturer:

ANGELBISS MEDICAL TECHNOLOGY CO., LTD
R2, NO.106, SHUANGHE ROAD, DIANSHANHU TOWN, KUNSHAN, 215345 JIANGSU, CHINA

Name and Address of Authorized Representative:

NURSE MEDICARE CO., LTD
No.15 Soi Thonburi 19 Yak 2, Bangwah, Phasri Charoen, Bangkok, 10160, Thailand

Medical Device(s):
Oxygen Concentrator [Model: ANGEL-20A, ANGEL-15A, ANGEL-10A, ANGEL-5A, ANGEL-5S,
ANGEL-5AB, ANGEL-3S, ANGEL-3A]

Risk Classification:
Classification (MDD, Annex IX) CLASS B, rule 11

Quality Management System Certificate:

ISO 13485, TUV SUD Product Service GmbH, NO. Q6 103610 0001 Rev. 00, Issue Date 2019-
12-20, Expiry Date 22-12-19

Standards Applied:
 
IEC 60601-1-2: 2014 (Edition 4.0)

Li Zhanli / CEO