CERTIFICATE
Certificate Registration No.: 12 100 26393 TMS / Order No.: 73590601

The Certification Bodyof TÜV SÜD Management Service GmbHcertifies that the organization

EIKEN CHEMICAL CO., LTD.
(Head Office)Yamaguchi Bldg. 7, 4-19-9 Taito, Taito-ku,
Tokyo 110-8408
Japanfor the scope

YP

Design and Development, Production and Distribution of
In-Vitro Diagnostic Reagents, calibrators and control materials for
Microbiological testing, Clinical chemical testing, Urine testing,
Immunochemical testing, Serological testing and Nucleic acid testing,Media and Reagents for Microbiological testing, Specimen receptacles andapparatus 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.

OC

including the sites see enclosure

has established and applies a Quality Management System.
An audit was performed and has furnished proof
that the requirements according toDIN EN ISO 9001:2015
are fulfilled.
The certificate is valid from 2024-07-31 until 2027-07-30.

Fred Wenke
Head of Certification Body
Munich, 2024-07-08
Page 1 of 2

ENCLOSURE OF CERTIFICATE
Certificate Registration No.: 12 100 26393 TMS / Order No.: 73590601
certificate holder:
EIKEN CHEMICAL CO., LTD.
(Head Office)Yamaguchi Bldg. 7, 4-19-9 Taito, Taito-ku,
Tokyo 110-8408
Japan
at the sites

scope

EIKEN CHEMICAL CO., LTD.
(Head Office)Yamaguchi Bldg. 7, 4-19-9 Taito, Taito-ku,
Tokyo 110-8408
Japan

Distribution of ln-Vitro Diagnostic Reagents, calibrators andcontrol materials for Microbiological testing, Clinical chemicaltesting, Urine testing, Immunochemical testing, Serological testingand Nucleic acid testing, Media and Reagents for Microbiologicaltesting, Specimen receptacles and apparatus for Clinical,
Food and Environmental testing and Reagents for Food andEnvironmental Analysis and Animal and Plant Diagnosis.
Design, Distribution, Installation and Servicing of
IVD Analyzers and related devices for specimen Collection.

EIKEN CHEMICAL CO., LTD.
(Nasu Plant)
1381-3, Shimoishigami, Otawara-shi,Tochigi 324-0036
Japan

Production and Distribution of ln-Vitro Diagnostic Reagents,
calibrators and control materials for Microbiological testing,
Clinical chemical testing, Urine testing, Immunochemical testing,
Serological testing and Nucleic acid testing, Media and Reagentsfor Microbiological testing, Specimen receptacles and apparatus
for Clinical, Food and Environmental testing and Reagents for
Food and Environmental Analysis and Animal andPlant Diagnosis.

EIKEN CHEMICAL CO., LTD.
(Nogi Plant)
143 Nogi, Nogi-machi, Shimotsuga-gun,Tochigi 329-0114
Japan

Design and Development, Production and Distribution ofln-Vitro Diagnostic Reagents, calibrators and control materials for
Microbiological testing, Clinical chemical testing, Urine testing,
Immunochemical testing, Serological testing and Nucleic acidtesting, Media and Reagents for Microbiological testing,Specimen receptacles and apparatus for Clinical,
Food and Environmental testing and Reagents for Food andEnvironmental Analysis and Animal and Plant Diagnosis.
Distribution of related devices for specimen collection.

EIKEN CHEMICAL CO., LTD.
(Europe Office)Burgemeester Haspelslaan 25
1181 NB Amstelveen
Netherlands

Support of local distributors sales promotion for ln-Vitro
Diagnostic Reagents, calibrators and control materials for
Microbiological testing, Clinical chemical testing, Urine testing,
Immunochemical testing, Serological testing and Nucleic acidtesting, Media and Reagents for Microbiological testing,Specimen receptacles and apparatus for Clinical, Food andEnvironmental testing and Reagents for Food andEnvironmental Analysis and Animal and Plant Diagnosis.
Support of local distributors performing installation andtechnical support for IVD Analyzers and related products.

YPOCFred Wenke
Head of Certification Body
Munich, 2024-07-08
Page 2 of 2