Announced details
Medical devices, home-use far-infrared blood circulation-promoting garments, and compliance with overseas medical device regulations
TENTIAL joined the Japan Medical Device Manufacturers Association as a full member and OMETA as a supporting member.
The Japan Medical Device Manufacturers Association was established in 1974 and obtained corporate status in 2009. It is an industry association for medical devices that conducts industry surveys and information gathering, promotes ISO and JIS standardization and internationalization, and holds training courses and seminars. OMETA is a nonprofit organization established on 21 July 1993. It was approved as an NPO by the Tokyo Metropolitan Government on 24 March 2000 and registered as a corporation on 5 April of the same year. Its activities include follow-up and after-sales care for medical equipment and other items provided to the healthcare sector in developing countries.
Class II medical device marketing authorization license, License No. 13B2X10608 (obtained in August 2024)
In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.
Japan Medical Device Manufacturers Association website, “About the Japan Medical Device Manufacturers Association”; Overseas Medical Equipment Technology Association website, “Activities”
| Item | Details |
|---|---|
| Names of Products / Services Covered | Conditioning brand TENTIAL, Recovery wear BAKUNE |
| Counterparty | Japan Medical Device Manufacturers Association, Overseas Medical Equipment Technology Association (OMETA) |
| Counterparty overview | The Japan Medical Device Manufacturers Association was established in 1974 and obtained corporate status in 2009. It is an industry association for medical devices that conducts industry surveys and information gathering, promotes ISO and JIS standardization and internationalization, and holds training courses and seminars. OMETA is a nonprofit organization established on 21 July 1993. It was approved as an NPO by the Tokyo Metropolitan Government on 24 March 2000 and registered as a corporation on 5 April of the same year. Its activities include follow-up and after-sales care for medical equipment and other items provided to the healthcare sector in developing countries. |
| Relationship with the Company | TENTIAL joined the Japan Medical Device Manufacturers Association as a full member and OMETA as a supporting member. |
| Applicable area | Medical devices, home-use far-infrared blood circulation-promoting garments, and compliance with overseas medical device regulations |
| Registration number and expiry date | Class II medical device marketing authorization license, License No. 13B2X10608 (obtained in August 2024) |
| Source | Japan Medical Device Manufacturers Association website, “About the Japan Medical Device Manufacturers Association”; Overseas Medical Equipment Technology Association website, “Activities” |
Items this document does not state (11)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.To deepen its knowledge of quality and safety management for medical devices and the regulatory requirements under the Pharmaceuticals and Medical Devices Act, and to contribute to the sound development of the industry. TENTIAL also aims to deepen its knowledge of overseas medical device regulations in preparation for the future global expansion of its business.