Certificates

EC Declaration of Conformity
Manufacturer:
whose single Authorized Representative:
K-JUMP HEALTH CO., LTD
NO.56, Wu Kung 5th Rd., New Taipei Industrial Park,
New Taipei City 24890, Taiwan
POLYGREEN GERMANY GmbH
Ruhlsdorfer Straβe 95, D-14532, Stahnsdorf,
Brandenburg, Germany
DIMDI Code: DE/0000044710
We, the manufacturer, herewith declare that the products
KD-1290(SC70), KD-1211(SC 44 flex), KD-122(SC 33 TM), KD-132(SC37T/
SC35T), KD-133(SC19 flex), KD-1351(SC17/SC18), KD-1471(SC28 flex),
KD-1501(SC41flex), KD-153(SC19 flex), KD-181(SC 42TM), KD-1491(SC29
flex), KD-2050 (SC 2050), KI-8172 (SC 8172), KI-8178 (SC 8178), KI-8271
(SC 8171), KI-8280 (SC 8280)
CLINICAL ELECTRONIC THERMOMETER
UMDNS-Code: 14-032
meet the provisions of Directive 93/42/EEC which apply to them.
The medical device has been assigned to class IIa according to Annex IX of the Directive
93/42/EEC. It bears the mark
0197
The product concerned has been designed and manufactured under a quality management
system according to Annex II (without the Annex II.4) of Directive 93/42/EEC and the
essential requirement of Annex I pertaining to medical devices.
Compliance of the designated product with the Directive 93/42/EEC has been assessed and
certified by the Notified Body
TÜ V Rheinland LGA Products GmbH
Tillystraße 2, 90431 Nürnberg, Germany
Registration No.: HD 60107452 0001
Issue date: 01.02.2016
Expiry date: 31.01.2021
following the procedure relating to the EC Declaration of Conformity set out in Annex II and
Annex VII of Directive 93/42/EEC.
This Declaration of conformity is valid in connection with the release document for the
respective batch of produced devices.
The above mentioned declaration of conformity is exclusively under the responsibility of
K-JUMP HEALTH CO., LTD
Taipei, 2020-04.29
Place , Date Natallie Guo / Sales Director