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2019

Certified Japan's first ISO-13485 for decellularized tissue for regenerative medical device and medicine

Oct. 07, 2019

ADEKA Corporation announced that certification ISO-13485:2016, an international quality management system for medical devices has issued to us as Japan's first decellularized tissue materials for medical implant.
 We will commit to accelerate for the development through co-developments with medical advisory board and/or prototype distribution to the ones who have its interest for the decellularized tissue as a surgical material.

In order for medical field's contribution, since 2013, we, ADEKA has been working on the developments for decellularized technologies used by xenograft, animal origin which enables acellular scaffolds for safety and quality human use.

Based on the long historical development background for chemicals and foods, we, ADEKA will continue and accelerate for this decellularized technology by animal origin aiming for medical market penetration.



◆Outline of ISO Certification

Applied Standards

ISO 13485:2016

Certificate No

Q5 101475 0001 Rev. 00

Date

August 7, 2019

Facilities

ADEKA Corporation, Arakawa Tokyo and ADEKA Corporation Kashima Plant-West, Kamisu-shi, Ibaraki

Scope of Certificate

Design and Development, Production and Distribution of Decellularized Animal Tissue Materials Utilized for Surgical Medical Devices

Certified Body

TUV SUD Japan LTD.



※1 About Decellularized Tissues for Medical use
Allograft or xenograft tissue from animal origin such as bovine or porcine with decellularized treatment by physically and/or chemically procedures for transplant (Extra Cellular Matrix: ECM) They are implementing in the clinical field in the overseas. We are aiming to develop safe and less rejection scaffolds.



■ Contacts
ADEKA Corporation
Publicity & Administration group, Legal Affairs & Publicity Department
TEL:+81-3-4455-2803

CONTACT

For inquiries about us, please contact us via inquiry form, telephone or fax.

For inquiries about us, please contact us by phone or fax.

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