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ISO Certification

EIKEN CHEMICAL CO., LTD. obtained ISO13485:2003 , ISO9001:2008 and ISO14001:2004 certification.

Applied Standard ISO13485:2016
Scope of Certificate
  • Design and Development, Production and Distribution of IVD reagents for Microbiological testing, Clinical chemical testing, Urine testing, Immunochemical testing, Serological testing and Nucleic acid testing.
    Production and Distribution of Swabs and Specimen containers for Microbiological testing.
    Design, Distribution, Installation and Servicing of IVD Analyzers and related devices for specimen collection.

Certification Body TÜV SÜD Product Service GmbH
Certification No. Q5 18 07 56540 021
Valid until 2021-06-24
Facilities Head Office, Nogi Plant, Nasu Plant, Sapporo Sales Office, Sendai Sales Office, Tokyo Sales Office I, Tokyo Sales Office II, Yokohama Sales Office, Nagoya Sales Office, Kyoto Sales Office, Osaka Sales Office, Hiroshima Sales Office, Takamatsu Sales Office, Fukuoka Sales Office, Europe Office
Applied Standard ISO9001:2015
Scope of Certificate
  • Design and Development, Production and Distribution of IVD Reagents for Microbiological testing, Clinical chemical testing, Urine testing, Immunochemical testing, Serological testing and Nucleic acid testing, Media and Reagents for Microbiological testing, Specimen receptacles and apparatus for clinical, Food and Environmental testing and Reagents for Food and Environmental Analysis and Animal and Plant Diagnosis.
    Design, Distribution, Installation and Servicing of IVD Analyzers and related devices for specimen collection.

Certification Body TÜV SÜD Management Service GmbH
Certification No. 12 100 26393 TMS
Valid until 2021-07-30
Facilities Head Office, Nogi Plant, Nasu Plant, Sapporo Sales Office, Sendai Sales Office, Tokyo Sales Office I, Tokyo Sales Office II, Yokohama Sales Office, Nagoya Sales Office, Kyoto Sales Office, Osaka Sales Office, Hiroshima Sales Office, Takamatsu Sales Office, Fukuoka Sales Office, Europe Office
Applied Standard ISO14001:2015
Certification Body TÜV SÜD Management Service GmbH
Certification No. 12 104 26393 TMS
Valid until 2021-04-16
Facilities
Sites Scope of application
Head Office

Administration, Sales of Testing Reagent and Diagnostic Equipment
Design and Debelopment of Diagnostic Equipment

Nogi Plant Design, Developments, Production and Delivery of Testing Reagent
Nasu Plant Design, Developments, Production and Delivery of Testing Reagent